Latest news with #immunoglobulin
Yahoo
2 days ago
- Business
- Yahoo
Heavy Insider Selling at ADMA Biologics Despite Earnings Strength
ADMA Biologics, Inc. (NASDAQ:ADMA) is one of the . The company witnesses significant insider sales amid strong growth and strategic advances reported in the Q1 earnings report. An independent distributor in their pharmacy with a range of biopharmaceutical products on display. Headquartered in New Jersey, ADMA Biologics, Inc. (NASDAQ:ADMA) is the only U.S.-based producer of plasma-derived immunoglobulin therapies. The company is engaged in the process of developing, manufacturing, and commercializing FDA-approved products, including ASCENIV, BIVIGAM, and Nabi-HB, to prevent and treat infectious diseases in immunodeficient and at-risk patients. On May 7, 2025, the company reported its first quarter earnings report for 2025. With a solid 40% year-over-year increase in total revenues, reaching $114.8 million, the company raised its 2025 revenue guidance to more than $500 million. Additionally, the company has also announced a $500 million stock repurchase program, which reflects its confidence in its financial stability. Later, on June 4, 2025, the company's top executives started selling the company's shares. Significant among them was the sales made by Director Steve Elms, who sold 425,621 shares, worth the value of $8,829,333. Despite the potential hit these transactions could have had on the investor's confidence, ADMA Biologics, Inc. (NASDAQ:ADMA)'s anticipated 5-year EPS growth continues to stand high at 39.37% while volatility remains low with a beta of 0.38. While we acknowledge the potential of ADMA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Metal Stocks with Insider Buying in 2025 and 10 Energy Stocks with Insider Buying in 2025 Disclosure. None. Sign in to access your portfolio
National Post
4 days ago
- Business
- National Post
Takeda Receives FDA 510(k) Clearance for HyHubTM and HyHubTM Duo Devices to Simplify HYQVIA® Administration
Article content HyHub and HyHub Duo Reduce the Number of Steps Required to Prepare HYQVIA 1 First Devices Customized for a Plasma-Derived Therapy in Takeda's Broad and Differentiated Portfolio Reflect Company's Commitment to Providing a Patient-Centric Ecosystem of Support Created With Input from Patients and Caregivers to Help Improve In-Home Infusion Article content OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub TM and HyHub TM Duo, devices for patients 17 years of age and older that allow HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting. 2 The HYQVIA administration process consists of dual vial units (DVUs) including one vial of immunoglobulin (IG) and one vial of hyaluronidase. HyHub and HyHub Duo, which act as docking stations for these vials, were developed to simplify administration of HYQVIA by reducing the number of steps required to prepare the infusion of two DVUs or more. 1 HYQVIA is a combination of IG and hyaluronidase for facilitated subcutaneous immunoglobulin (SCIg) infusion that is approved for treatment of adults and children two years of age and older with primary immunodeficiency (PI) and as maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in the United States. 2 Depending on the indication, HYQVIA can be infused up to once monthly (every two, three or four weeks). Article content 'This milestone exemplifies our dedication to advancing innovative solutions that can enhance the treatment administration experience for people who rely on infusions of facilitated immunoglobulin like HYQVIA,' said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit. 'We designed HyHub and HyHub Duo, Takeda's first customized devices for use with a plasma-derived therapy, with input from patients and caregivers, demonstrating our focus on leveraging technology and deep insights to offer a patient-centric ecosystem of support throughout the treatment journey.' Article content HyHub and HyHub Duo reduce the number of steps required to prepare the IG and hyaluronidase of the HYQVIA infusion by up to half compared to infusing with a pooling bag depending on the device and number of DVUs used. 1* HyHub and HyHub Duo also reduce the ancillary supplies required to prepare the infusion and a dedicated carrier bag is available for convenience that enables room-to-room mobility. 3 'For people living with primary immunodeficiency, innovative devices that can help simplify the administration process of their immunoglobulin treatment can be especially meaningful as many require lifelong treatment for their disease,' said Jorey Berry, president and chief executive officer of the Immune Deficiency Foundation. Article content HyHub and HyHub Duo are intended for use only with HYQVIA and the devices will be available at no additional cost to patients. Article content Takeda anticipates making HyHub and HyHub Duo available in the United States starting in the second half of fiscal year 2025. Takeda also submitted a CE Mark application for HyHub and HyHub Duo in the European Union during the first quarter of fiscal year 2025 and will evaluate making the device available in other markets in the future. Article content * HyHub reduces the number of steps by approximately half for four DVUs. HyHub Duo reduces the number of steps by about one third for two DVUs. Article content ® Article content is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and is approved in the United States to treat adults and children two years of age and older with primary immunodeficiency (PI), and as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adult patients with CIDP. It is also approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with PI and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. In addition, it is approved by the EMA as maintenance therapy in adults, children and adolescents (0-18 years) with CIDP after stabilization with intravenous immunoglobulin therapy (IVIG). HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body's immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI). Article content HyHub/HyHub Duo Important Information for Healthcare Providers Article content Intended Use: Article content HyHub/HyHub Duo are stand-alone, single-use, disposable vial access devices. Article content Indications for Use: Article content HyHub/HyHub Duo are indicated for patients 17 years of age and older to allow HYQVIA [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting. Article content Contraindications: Article content Do not use HyHub/HyHub Duo with a pooling bag. Do not connect HyHub/HyHub Duo to a syringe driver infusion pump. Article content Selected Information for Patients: Article content HyHub/HyHub Duo are for SINGLE USE ONLY, even if all docks are not used during a single infusion. Re-use will increase risk of infection. Patients should always use a new HyHub/HyHub Duo for each infusion. Only use HyHub/HyHub Duo when patients are ready to administer HYQVIA. Patients should not use HyHub/HyHub Duo at home until receiving instructions and training from a healthcare provider. HYQVIA is the only medication that may be used with HyHub/HyHub Duo. Patients should not exceed the maximum infusion volume per infusion site or infusion rate as indicated in the HYQVIA prescribing information. Article content For safe and proper use of HyHub/HyHub Duo, please refer to the complete Instructions for Use included with the devices when they become available in the second half of FY2025. Article content For information about HYQVIA, please see Prescribing Information for HYQVIA. Article content INDICATIONS FOR HYQVIA Article content HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older and for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HYQVIA is for subcutaneous use only. Article content WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. Article content Contraindications Article content History of anaphylactic or severe systemic hypersensitivity reactions to human IG IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA Known systemic hypersensitivity to human albumin (in the hyaluronidase solution) Article content Warnings and Precautions Article content Hypersensitivity: Article content Severe hypersensitivity reactions may occur, even in patients previously treated with IG products. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis. Article content Thrombosis: Article content Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Article content Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Article content Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Article content Aseptic Meningitis Syndrome: Article content Has been reported to occur with use of IG, including HYQVIA. The syndrome usually begins within several hours to two days following IG treatment. Article content Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. Article content Hemolysis: Article content HYQVIA contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing. Article content Renal Dysfunction/Failure: Article content Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, may occur with IG products, including HYQVIA. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, administer HYQVIA at the minimum rate of infusion practicable. Assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation. Article content Spread of Localized Infection: Article content Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection. Article content Transfusion-Related Acute Lung Injury: Article content Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. Manage using oxygen therapy with adequate ventilatory support. Article content Transmittable Infectious Agents: Article content Because HYQVIA is made from human plasma, there is a risk of transmitting infectious agents (e.g. viruses, other pathogens). Article content Interference with Lab Tests: Article content False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Article content Adverse Reactions Article content The most common adverse reactions observed in >5% of patients in the clinical trials were: Article content Primary Immunodeficiency (PI) Article content : Local reactions, headache, antibody formation against rHuPH20, fatigue, nausea, pyrexia, and vomiting. Article content Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Article content : Local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity. Article content Drug Interactions Article content Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). Article content Use in Specific Populations Article content Pregnancy: Article content Limited human data are available on the use of HYQVIA during pregnancy. The effects of antibodies to the Recombinant Human Hyaluronidase on the human embryo or fetal development are unknown. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HYQVIA should be given to a pregnant woman only if clearly needed. Article content Please click for Article content For European Union Summary of Product Characteristics, please visit: Article content About Takeda Article content Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit Article content . Article content For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. Article content Article content The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Article content Forward-Looking Statements Article content This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could' 'anticipates', 'estimates', 'projects' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Article content Article content . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Medical information Article content This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Article content Data on File. Takeda Pharmaceuticals. Article content Article content Article content Article content View source version on Article content Article content Contacts Article content U.S. Media Taryn Corbino +1 (617) 588-8737 Article content Article content
Health Line
15-07-2025
- Health
- Health Line
Understanding the Types of Multiple Myeloma
Key takeaways The types of active multiple myeloma are categorized by the overproduced immunoglobulin, with IgG being the most common and IgE the rarest and most aggressive. Smoldering multiple myeloma is a precancerous condition without symptoms that can progress to active myeloma, requiring monitoring but not always immediate treatment. Multiple myeloma is a cancer of the plasma cells. Plasma cells are found in the bone marrow. They help your body produce immune system proteins, also known as immunoglobulins or antibodies, that target and destroy pathogens. Pathogens are disease-causing organisms. With multiple myeloma, plasma cells multiply too quickly. They overproduce an irregular protein called a monoclonal protein (M protein). Unlike a healthy immune system antibody, this protein cannot fight pathogens. Common symptoms of myeloma include bone pain, fatigue, and nausea, but not everyone experiences them. This article overviews multiple myeloma types and subtypes and their features. Smoldering vs. active multiple myeloma Smoldering multiple myeloma (SMM) is a precancerous condition that can develop into multiple myeloma over time. People with SMM don't have symptoms, so they're not likely to know they have it. Indeed, most cases are detected incidentally. For example, a doctor might notice increased protein levels during a routine blood or urine test and discover SMM upon further testing. If you have SMM, you may not require any treatment. A doctor might suggest regular monitoring to look for signs of your condition progressing to active myeloma. How often does smoldering multiple myeloma become active? Most cases of SMM eventually progress to active multiple myeloma. According to research cited in a 2022 article: SMM carries a 50% risk of progressing to myeloma within 5 years. SMM carries a 65% risk of progressing to myeloma within 10 years. About 25% of people with SMM never develop myeloma symptoms. Still, the risk can vary a lot from person to person. Higher M protein levels and bone marrow plasma cell percentages carry a higher risk of progression to myeloma within a few years. Types of active multiple myeloma In contrast to healthy plasma cells, myeloma cells only produce one type of immunoglobulin, resulting in a surplus of that type. Myeloma is categorized according to the type of immunoglobulin that's overproduced. There are five types: IgG myeloma: This is the most common type. In a 2020 study including 8,468 people with myeloma, about 57% had IgG. IgA myeloma: In the same study, IgA accounted for 20% of myeloma cases. According to 2020 research, IgA may have lower long-term survival rates than IgG. IgM myeloma: While similar to IgG and IgA, this type is much rarer, making up only 1% of myeloma cases. Overproduction of IgM usually develops into other disorders, like Waldenstrom macroglobulinemia. IgD myeloma: This rare type accounts for less than 2% of myeloma cases. It's more common in males and more likely to start at a younger age. It's typically more aggressive. IgE myeloma: Only 0.1% of myeloma cases are IgE, making it the rarest type. It's more aggressive than other types and has lower survival rates. Light-chain myeloma Light-chain myeloma is the third most common type of multiple myeloma after IgG and IgA. It makes up about 15% of myeloma cases, according to a 2018 review. The term 'light chain' refers to the structure of immunoglobulins, which have two larger heavy chains and two smaller light chains. In light-chain myeloma, myeloma cells produce incomplete immunoglobins that do not have heavy chains. They only have light chains, also known as Bence-Jones proteins. Nonsecretory myeloma Nonsecretory myeloma is a rare form of myeloma that accounts for around 3–5% of cases. It occurs when cancerous myeloma cells are present in the bone marrow but don't make or release any immunoglobulins. This type of myeloma is sometimes more challenging to detect since it doesn't cause elevated levels of immunoglobulins in urine or blood. Doctors may use bone marrow scans, such as CT scans or PET scans, to make a diagnosis. Related plasma chain disorders Myeloma is a type of plasma chain or plasma cell disorder. That means it affects plasma cells' ability to produce immunoglobulins or antibodies. Related plasma chain disorders include: MGUS Monoclonal gammopathy of undetermined significance (MGUS) is a relatively common condition in which M proteins are present in your blood without affecting your health. Different countries have reported MGUS rates ranging from 0.05–6.1%. It's more common among certain groups, such as older adults and Black people. MGUS doesn't usually cause symptoms. Only around 1% of people who have it go on to develop active myeloma each year. Doctors typically suggest monitoring MGUS with regular blood tests. Solitary plasmacytoma A plasmacytoma is a plasma cell tumor. Most plasma cell tumors, including myeloma tumors, grow in the bone marrow. Multiple myeloma causes many tumors in bone marrow all over the body. In contrast, solitary plasmacytoma only causes one tumor. Because solitary plasmacytoma is limited to a single area, it's easier to treat. Doctors can usually remove the tumor via radiation, surgery, or both. Extramedullary plasmacytoma Extramedullary plasmacytoma occurs when a single plasma cell tumor grows in soft tissue rather than bone. In a 2022 study, 62% of these tumors were in the head and neck area. As with solitary plasmacytoma, the cancer is localized to a single area, and treatment with radiation or surgery is usually effective. Light-chain amyloidosis Light-chain amyloidosis is when light-chain proteins produced by abnormal plasma cells accumulate throughout the body. These deposits, known as amyloid deposits, can lead to organ damage. This condition can occur independently of myeloma cancer. However, it can also be a complication of multiple myeloma. Waldenstrom macroglobulinemia Waldenstrom macroglobulinemia (WM) is a rare form of cancer that shares features in common with multiple myeloma. WM cells overproduce IgM, an M protein that's sometimes overproduced in myeloma. Despite this similarity, experts classify WM as a type of non-Hodgkin's lymphoma because it affects the lymphatic system. Hyperdiploid vs. hypodiploid myeloma Doctors sometimes classify multiple myeloma tumors according to the number of chromosomes found in tumor cells: Hyperdiploid myeloma tumors have 47–74 chromosomes. Hypodiploid myeloma tumors have 44 or fewer chromosomes. The authors of a 2021 case report cite research suggesting that hyperdiploid multiple myeloma is typically less aggressive than the hypodiploid type. Frequently asked questions What is the most common type of multiple myeloma? Accounting for more than 50% of all myelomas, IgG is the most common type of multiple myeloma. The next most common types are IgA and light-chain myeloma. What is the most aggressive type of multiple myeloma? According to a 2020 study, IgA and light-chain myeloma are associated with poorer overall survival than other common types. The median overall survival was 4.7 years after diagnosis for people with IgA myeloma and 4.8 years after diagnosis for people with light-chain myeloma. The Canadian Cancer Society reports that IgE is the most aggressive type of myeloma. However, it is extremely rare. What is the difference between kappa and lambda multiple myeloma? Kappa and lambda are two types of light chains. In multiple myeloma, one or the other may be overproduced. According to a 2017 study, myeloma with lambda light chains carries a poorer overall outlook. Takeaway Multiple myeloma is a cancer that causes uncontrolled plasma cell growth. The hallmark of myeloma is the presence of M proteins in blood or urine. The type of M protein overproduced determines the type of myeloma.
National Post
30-06-2025
- Business
- National Post
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content1
Article content GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency 1 U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026 Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company's Differentiated Immunoglobulin Portfolio of Ready-to-Use Liquids 2 Article content OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously. 1 'The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,' said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit. 'GAMMAGARD LIQUID ERC uses the same state-of-the-art manufacturing process as our other ready-to-use liquid immunoglobulin formulations and is aligned with our forward-looking strategy to prioritize reliable supply while offering a broad range of immunoglobulin therapies to address varied patient needs.' Article content With this approval, Takeda continues to be the only manufacturer of IG therapy with low IgA content less than or equal to 2 µg/mL in a 10% solution. 1 It is anticipated that commercialization of GAMMAGARD LIQUID ERC will begin in the U.S. in 2026, followed by the European Union in 2027, where GAMMAGARD LIQUID ERC is approved by the European Medicines Agency (EMA) as DEQSIGA ®. 3 The timeline to commercial launch is consistent with the time it takes to ramp up manufacturing and supply for plasma-derived therapies. Article content In parallel to this approval, and after thorough analysis, Takeda has decided to discontinue GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, the company's first-generation low IgA product. 2 As the only lyophilized (freeze-dried) preparation in Takeda's IG portfolio, GAMMAGARD S/D uses a different, older manufacturing process. For GAMMAGARD S/D, this process is no longer able to reliably meet the future needs of the patient community. Therefore, Takeda has informed the FDA and other health authorities that manufacturing of GAMMAGARD S/D will be discontinued at the end of December 2027. Beyond that date, Takeda intends to maintain GAMMAGARD S/D inventory until it is depleted or expired. Article content 'We understand the impact that this news may have on patients who currently rely on GAMMAGARD S/D for their treatment,' said Kristina Allikmets. 'We are communicating this information now to allow time for patients to work closely with their health care teams to develop alternative treatment plans.' Article content GAMMAGARD LIQUID ERC is a ready-to-use liquid immunoglobulin therapy with an IgA content of less than or equal to 2 µg/mL in a 10% solution to be administered intravenously or subcutaneously. It is indicated in the United States as replacement therapy for primary immunodeficiency (PI) in people two years of age and older. Article content 1 Article content GAMMAGARD LIQUID ERC shares its manufacturing process with GAMMAGARD LIQUID [Immune Globulin Infusion (Human)], with the modification of parameters in a single process step to improve IgA reduction. This enhanced removal capability (ERC) results in a product with IgA less than or equal to 2 µg/mL in a 10% solution. 1 While GAMMAGARD LIQUID ERC is not indicated specifically for IgA sensitivity in people with primary immunodeficiency, it may be an appropriate option for them based on their physician's clinical judgment. GAMMAGARD LIQUID ERC is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to the product. It also carries warnings and precautions regarding the potential for severe hypersensitivity reactions, including in patients who have previously tolerated immune globulin products. Despite containing low levels of IgA (≤2 µg/mL in a 10% solution), the risk of anaphylaxis remains. 1 About GAMMAGARD S/D GAMMAGARD S/D is lyophilized (freeze-dried) immunoglobulin therapy with IgA content less than 1 µg/mL in a 5% solution for intravenous use only. It is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic immune thrombocytopenic purpura (ITP) to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. 2 About Primary Immunodeficiency (PI) Primary immunodeficiency (PI) is a group of more than 550 rare and chronic disorders, where a part of the body's immune system is missing or does not function the way it should. 4 These conditions result from genetic mutations, which are usually inherited. 5 The symptoms of PI vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists. 6 In the United States, PI affects about 1 in 1,200 people. 7 GAMMAGARD LIQUID ERC, GAMMAGARD LIQUID and GAMMAGARD S/D U.S. Important Safety Information WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. WARNING: RENAL DYSFUNCTION and ACUTE RENAL FAILURE Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products, including GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC and GAMMAGARD S/D do not contain sucrose. Contraindications GAMMAGARD LIQUID is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to human IG, and IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID. GAMMAGARD LIQUID ERC and GAMMAGARD S/D are contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD LIQUID ERC and GAMMAGARD S/D. Warnings and Precautions Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis. Article content Renal Dysfunction/Failure: Article content GAMMAGARD LIQUID Article content and Article content GAMMAGARD S/D Article content . Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation. Article content may occur. It is critical to distinguish true hyponatremia from pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events. Article content Thrombosis: Article content Has been reported to occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Article content Aseptic Meningitis Syndrome: Article content Has been reported with use of IG. Article content Article content Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. The syndrome usually begins within several hours to two days following IG treatment Article content Hemolysis: GAMMAGARD LIQUID Article content , Article content GAMMAGARD LIQUID ERC, Article content and Article content GAMMAGARD S/D Article content contain blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing. Article content Transfusion-Related Acute Lung Injury: Article content GAMMAGARD LIQUID Article content . Article content Article content Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support. Article content Transmittable Infectious Agents: Article content Because Article content GAMMAGARD LIQUID Article content , Article content GAMMAGARD LIQUID ERC, Article content and Article content GAMMAGARD S/D Article content are made from human plasma, they may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with Article content GAMMAGARD LIQUID. Article content positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Article content Alterations in serum sodium levels Article content GAMMAGARD S/D Article content . In patients on a low sodium diet, calculate the amount of sodium from Article content GAMMAGARD S/D Article content when determining dietary sodium intake. Article content Adverse Reactions Article content GAMMAGARD LIQUID Article content IV administration: Article content The serious adverse reaction seen during IV clinical trials was aseptic meningitis. The most common adverse reactions observed in ≥5% of patients in clinical trials were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur. Article content Subcutaneous administration: Article content The most common adverse reactions observed in ≥5% of patients in clinical trials were infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity. Article content GAMMAGARD LIQUID ERC Article content The safety of GAMMAGARD LIQUID ERC in patients with primary humoral immunodeficiency (PI) is supported by two clinical studies conducted on GAMMAGARD LIQUID. No clinical studies have been conducted using GAMMAGARD LIQUID ERC. Article content IV administration: Article content The most common adverse reactions observed in ≥5% of patients in study 1 were headache, fatigue, pyrexia, chills, nausea, pain in extremity, diarrhea, migraine, vomiting, dizziness, urticaria, cough, asthma, oropharyngeal pain, infusion site extravasation, arthralgia, rash, myalgia, pruritis, and cardiac murmur. Article content Subcutaneous administration: Article content The most common adverse reactions observed in ≥5% of patients in study 2 were infusion site (local) event, headache, pyrexia, fatigue, heart rate increased, abdominal pain upper, vomiting, arthralgia, nausea, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous ulcer, migraine, oropharyngeal pain, and pain in extremity. Article content GAMMAGARD S/D Article content The most common adverse reactions observed in ≥5% of clinical trial patients during or within 48 hours of infusion were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis, and flushing. Article content The most serious adverse reactions reported postmarketing include renal failure, thrombotic events (myocardial infarction, cerebrovascular accidents, and pulmonary embolism), anaphylactic shock, aseptic meningitis, and hemolysis. Article content Drug Interactions Article content Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). Article content For Full U.S. Prescribing Information for GAMMAGARD LIQUID, please visit: Article content For Full U.S. Prescribing Information for GAMMAGARD LIQUID ERC, please visit: Article content Article content For Full U.S. Prescribing Information for GAMMAGARD S/D, please visit: Article content For European Union Summary of Product Characteristics for DEQSIGA, please visit: Article content About Takeda Article content Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. 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Any failure to comply with these restrictions may constitute a violation of applicable securities laws. Article content The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Article content Forward-Looking Statements Article content This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. 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Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Medical Information Article content This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. 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Medscape
30-06-2025
- Health
- Medscape
Which Immunoglobulin Route Best Prevents Infections?
TOPLINE: In patients with inborn errors of immunity who are prone to viral infections, immunoglobulin replacement therapy (IRT) administered via the conventional subcutaneous route showed lower viral infection rates than the intravenous and facilitated subcutaneous routes. METHODOLOGY: Researchers conducted a cross-sectional study to compare the incidence of viral infections among immunocompromised patients who had been receiving IRT via different administration routes for more than 5 years. They included 58 patients (56.8% boys; median age, 17 years; median age at diagnosis, 11.5 years) with inborn errors of immunity. The intravenous route was the most common route of immunoglobulin administration (n = 32), followed by the conventional subcutaneous (n = 16) and facilitated subcutaneous (n = 10) routes. Patients underwent monitoring of immunoglobulin levels and had nasal swab collected monthly, with viral infections recorded when symptoms such as runny nose, cough, or fever were present. Infections from different immunoglobulin administration routes were analyzed by polymerase chain reaction testing of nasal swabs and serum immunoglobulin levels using nephelometry. TAKEAWAY: The overall viral infection frequency was 3.79%, with rates of 4.2% for the intravenous route, 2.5% for the conventional subcutaneous route, and 4.4% for the facilitated subcutaneous route of immunoglobulin administration. The conventional subcutaneous route associated with significantly lower infection rates than the other routes (P < .05). Adenovirus (21.8%), influenza A virus (16.4%), and human rhinovirus/enterovirus (16.4%) were the most frequently detected viral agents. At 3 months, patients with X-linked agammaglobulinemia (6.06%) and those with common variable immunodeficiency (3.65%) had the highest rates of viral infections. IN PRACTICE: 'Shared decision-making between patients and healthcare professionals is critical in determining the most appropriate administration route and product to minimize the risk of infections and achieve optimal treatment outcomes,' the authors wrote. SOURCE: The study was led by Hulya Kose, Department of Pediatric Immunology and Rheumatology, Uludağ University Faculty of Medicine, Bursa, Turkey. It was published online on May 30, 2025, in the European Journal of Pediatrics. LIMITATIONS: This research had limitations due to the small sample size within specific patient subgroups. DISCLOSURES: The study did not receive any specific funding. The authors declared having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
