Latest news with #IgA
Time of India
21-07-2025
- Health
- Time of India
10 surprising symptoms of Celiac disease you might be ignoring
Celiac disease , often thought of as causing only digestive issues like bloating, diarrhea, or abdominal pain, affects approximately 1% of the global population. While the disease is common, many cases remain undiagnosed. However, this autoimmune disorder, triggered by gluten in wheat, rye, and barley, can manifest in dozens of unexpected ways. If left undiagnosed, it can silently contribute to long-term complications like osteoporosis, neurological decline, and infertility. Unchecked celiac disease often results in symptoms affecting your skin, bones, nervous system, reproductive health, and more. However, recognizing common signs, an early diagnosis, and a strict gluten-free diet can transform your quality of life, fixing hidden health problems and preventing serious long-term complications. In this article, we'll unveil ten surprising yet telling symptoms of celiac disease that you may unknowingly be ignoring. Dermatitis Herpetiformis Unlike eczema or psoriasis, dermatitis herpetiformis (DH) is unique to celiac disease: small, intensely itchy clusters of blisters appear on elbows, knees, scalp, or buttocks. These itchy blistering rashes happen due to IgA antibody deposits in the skin, triggered by gluten. Though only about 5-10% of patients exhibit DH, it's a definitive cutaneous marker of underlying gluten-triggered autoimmunity, and often clears completely on a gluten-free diet. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 15 most beautiful women in the world Undo Iron‑deficiency anemia and consistent fatigue Iron is absorbed in the part of the small intestine typically damaged by celiac disease. Malabsorption in the damaged upper small intestine inhibits iron absorption, leading to chronic iron-deficiency anemia. This common yet often overlooked effect paints a portrait of persistent fatigue, pale complexion, shortness of breath, and weakness. In fact, as per the Celiac Disease Foundation , nearly 11% of unexplained iron-deficiency anemia cases are later diagnosed as celiac disease. Addressing anemia without investigating underlying causes can delay an important diagnosis. Peripheral neuropathy (tingling, numbness, burning) According to the Mayo Clinic , up to 10% of celiac patients experience peripheral neuropathy or nerve damage. Symptoms of peripheral neuropathy include tingling, burning, or numbness in the hands and feet, even when no digestive signs are present. According to a 2021 study , the prevalence may be even higher (up to 42%) in untreated cases and is thought to stem from nutrient malabsorption and immune-mediated nerve damage. Migraines, headaches, and brain fog Frequent headaches, migraines, and cognitive haziness, or ' brain fog ', are surprisingly common symptoms in the case of celiac disease, which people tend to ignore. Chronic inflammation, nutrient deficiencies (like B vitamins), and gluten-related neurological impacts can dull concentration and memory. These neurological symptoms often improve substantially on a gluten-free diet. Joint pain and arthralgia This one's to be taken note of. Many patients report joint aches or stiffness, sometimes diagnosed as arthritis. Arthralgia, or joint pain and stiffness, often misdiagnosed as arthritis, can be the result of systemic immune inflammation caused by gluten exposure. As per a 2018 study , nearly 30% of patients report joint improvement after eliminating gluten. Bone density loss, osteoporosis, and fracture risk In celiac disease, damage to the small intestine reduces calcium and vitamin D absorption, compromising bone health , leading to an elevated risk of osteomalacia, osteopenia, osteoporosis, and fractures, even in younger adults. Many individuals don't recognize bone weakness until bone scans reveal it. Maintaining strong bones requires both nutrition and gluten removal. Reproductive challenges (infertility, miscarriage, hormonal irregularities) Malabsorption and chronic inflammation can impair reproductive health. Women with undiagnosed celiac may experience irregular cycles, amenorrhea, infertility, or recurrent miscarriages. As the Mayo Clinic suggests, adhering to a gluten-free diet can normalize fertility and reduce pregnancy complications. Oral health issues (canker sores and enamel defects) These are not common oral issues we are talking about that come to pay us a vist once in a while. Persistent mouth ulcers, burning tongue (atrophic glossitis), and serious dental enamel problems like pitting or translucent spots are often associated with celiac disease due to malabsorption of vitamins B12, folate, and minerals. In children, enamel defects may even signal undiagnosed celiac long before other symptoms emerge. Mood disorders (anxiety, depression, cognitive decline) This is more than simple mood swings. Celiac disease, as per research , is increasingly linked to mental health issues such as anxiety, depression, mood swings, ADHD-like attention problems, and even insomnia. These neuropsychiatric symptoms may result from autoimmune processes, nutrient depletion, or chronic inflammation. Many individuals report improved mood and mental clarity post-diagnosis. Vertigo, balance issues, and ataxia Gluten-related neurological impacts aren't limited to headaches. Conditions like gluten ataxia , characterized by poor coordination, dizziness, involuntary eye movements, and balance issues, can occur in celiac sufferers. If left untreated, motor dysfunction may become permanent. Why early detection is important: Celiac disease, estimated to affect up to 1% of people worldwide, remains undiagnosed in up to 70–80% cases, often because they don't show classic digestive complaints. These 'non-classic' symptoms can manifest across multiple systems. Persistent unexplained issues in any of these areas indicate a celiac evaluation, which might include serology tests (tTG-IgA) and confirmatory small-bowel biopsy. If you endure persistent, unexplained symptoms, even in the absence of digestive distress, don't overlook celiac disease. Consult with a healthcare provider and get tested. Early diagnosis and a strict gluten-free diet can transform your quality of life, fixing hidden health problems and preventing serious long-term complications. Heart Failure Warning: 4 Symptoms You Might Be Overlooking
Yahoo
01-07-2025
- Health
- Yahoo
FDA approves Takeda's Gammagard liquid ERC for primary immunodeficiency
The US Food and Drug Administration (FDA) has approved Takeda's new immunoglobulin (IG) therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat primary immunodeficiency (PI) in individuals aged two years and above. PI is typically caused by genetic mutations that can be passed down through families. Symptoms vary widely and often include recurring or long-lasting infections. Gammagard liquid ERC is the only ready-to-use liquid IG therapy with less than or equal to 2µ/ml two micrograms per millilitre of Immunoglobulin A (IgA) in a 10% solution, and can be administered either intravenously or subcutaneously. Takeda plasma-derived therapies business unit research and development senior vice-president and head Kristina Allikmets stated: 'The approval of Gammagard liquid ERC reinforces our commitment to supporting individualised 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. '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 prioritise reliable supply while offering a broad range of immunoglobulin therapies to address varied patient needs.' Takeda anticipates commencing commercialisation efforts for Gammagard liquid ERC in the US by 2026, with plans to follow suit in the European Union (EU) by 2027. Gammagard liquid ERC is approved under the brand name Deqsiga by the European Medicines Agency. In June 2025, the European Commission authorised Takeda's Adcetris (brentuximab vedotin), an antibody-drug conjugate, combined with chemotherapy for treating adults who are newly diagnosed with Stage IIb Hodgkin's lymphoma with risk factors or at Stage III/IV. "FDA approves Takeda's Gammagard liquid ERC for primary immunodeficiency" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
30-06-2025
- Business
- Business Wire
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.' 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. 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. '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.' About GAMMAGARD LIQUID ERC 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. 1 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. Expand 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. Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Acute renal failure has been reported in association with GAMMAGARD LIQUID and GAMMAGARD S/D. 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. Hyperproteinemia, increased serum viscosity, and hyponatremia 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. Thrombosis: 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. Aseptic Meningitis Syndrome: Has been reported with use of IG. 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 Hemolysis: GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC, and GAMMAGARD S/D 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. Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema has been reported with IV-administered IG, including GAMMAGARD LIQUID. 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. Transmittable Infectious Agents: Because GAMMAGARD LIQUID, GAMMAGARD LIQUID ERC, and GAMMAGARD S/D 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 GAMMAGARD LIQUID. Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Alterations in serum sodium levels (i.e., acute hypernatremia, pseudohyponatremia) may occur with GAMMAGARD S/D. In patients on a low sodium diet, calculate the amount of sodium from GAMMAGARD S/D when determining dietary sodium intake. Adverse Reactions GAMMAGARD LIQUID IV administration: 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. Subcutaneous administration: 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. GAMMAGARD LIQUID ERC 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. IV administration: 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. Subcutaneous administration: 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. GAMMAGARD S/D 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. 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. Drug Interactions Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). About Takeda 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. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice 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. 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. Forward-Looking Statements 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 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. Medical Information 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.
Yahoo
30-06-2025
- Business
- Yahoo
Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET ROCKVILLE, Md. & EDMONTON, Alberta, June 30, 2025--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects. Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1. Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively. "Dual inhibition of BAFF and APRIL to modulate B cells, including plasma cells, holds great promise in the treatment of a wide range of autoimmune immune diseases where these cells produce disease-causing autoantibodies," said Dr. Greg Keenan, Chief Medical Officer of Aurinia. "Based on today's positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year." Webcast & Conference Call Details A webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA‑approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with the development of aritinercept and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at and on Aurinia's website at View source version on Contacts General Investor Inquiries ir@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
30-06-2025
- Business
- Business Wire
Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects. Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1. Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively. 'Dual inhibition of BAFF and APRIL to modulate B cells, including plasma cells, holds great promise in the treatment of a wide range of autoimmune immune diseases where these cells produce disease-causing autoantibodies,' said Dr. Greg Keenan, Chief Medical Officer of Aurinia. 'Based on today's positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.' Webcast & Conference Call Details A webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA‑approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Forward-Looking Statements This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with the development of aritinercept and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at and on Aurinia's website at
