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Yahoo
08-07-2025
- Health
- Yahoo
Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia TITUSVILLE, N.J., July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey. "For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode," said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York.a "CAPLYTA® substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families." The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007). The safety profile of CAPLYTA® was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.i Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of On average, an adult with schizophrenia experiences nine relapses in less than six "Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression. We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA® and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders." While its exact mechanism of action is unknown, CAPLYTA® is characterized by high serotonin 5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA® was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA® can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose. CAPLYTA® is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An sNDA for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA® has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders. Editor's note: a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. About Schizophrenia Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – "the critical period" – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly.v,vi A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with About Study 304This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. About CAPLYTA® (lumateperone) CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. CAPLYTA® is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA® is not FDA-approved for these disorders. CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Important Safety Information Boxed Warnings: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients. Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria. Warnings & Precautions: Antipsychotic drugs have been reported to cause: Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above. Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room. Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued. Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment. Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors. Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension. Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA. Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold. Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them. Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics. Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration. Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors. Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment. Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules. Please click here to see full Prescribing Information including Boxed Warnings. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. © Johnson & Johnson and its affiliates 2025. All rights reserved. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of CAPLYTA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes i Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia. GlobeNewswire, 05 Nov. 2024, ii "Schizophrenia Fact Sheet." Treatment Advocacy Center, 10 Mar. 2025, iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy. Int Clin Psychopharmacol. 2016;31(4)202-209. doi:10.1097/YIC.0000000000000125 iv Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705 v Birchwood, M. "Early intervention and sustaining the management of vulnerability." The Australian and New Zealand journal of psychiatry vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241 vi Tandon, Rajiv et al. "The schizophrenia syndrome, circa 2024: What we know and how that informs its nature." Schizophrenia research vol. 264 (2024): 1-28. doi:10.1016/ View original content to download multimedia: SOURCE Johnson & Johnson
Yahoo
16-06-2025
- Business
- Yahoo
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025 Initial Phase 1 clinical data is expected in the first half of 2026 NextCure also gains rights to Simcere Zaiming's proprietary linker and payload for use in an ADC directed to a NextCure novel target; Simcere Zaiming will have rights to greater China BELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025. SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration. The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC. 'We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,' said Michael Richman, NextCure's president and CEO. 'We look forward to initiating clinical development of SIM0505 in the United States.' 'We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure's recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.' Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory. About NextCure, is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere ZaimingSimcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. NextCure's Cautionary Statement Regarding Forward-Looking StatementsSome of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'continue,' 'could,' 'should,' 'due,' 'estimate,' 'expect,' 'intend,' 'hope,' 'may,' 'objective,' 'plan,' 'predict,' 'potential,' 'positioned,' 'seek,' 'target,' 'towards,' 'forward,' 'later,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure's limited operating history and not having any products approved for commercial sale; NextCure's history of significant losses; NextCure's need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure's ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure's dependence on key personnel. More detailed information on these and additional factors that could affect NextCure's actual results are described under the heading 'Risk Factors' in NextCure's most recent Annual Report on Form 10-K and in NextCure's other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NextCure Investor InquiriesTimothy Mayer, Operating Officer(240) 762-6486IR@ Simcere Zaiming ContactsPR contacts: pr@ contacts: ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
05-06-2025
- Business
- Yahoo
Global Antidote Market to Cross the USD 4 Billion Mark by 2032
The antidote market is witnessing substantial growth, largely propelled by the growing incidence of poisoning, drug overdoses, and snake or animal bites. This rising demand is supported by greater public health awareness, government efforts to combat drug overdoses, and continuous progress in product innovation. Moreover, strategic product launches and technological advancements by key industry players in the treatment of toxicities are further accelerating the market's upward momentum. New York, USA, June 05, 2025 (GLOBE NEWSWIRE) -- Global Antidote Market to Cross the USD 4 Billion Mark by 2032 | DelveInsight The antidote market is witnessing substantial growth, largely propelled by the growing incidence of poisoning, drug overdoses, and snake or animal bites. This rising demand is supported by greater public health awareness, government efforts to combat drug overdoses, and continuous progress in product innovation. Moreover, strategic product launches and technological advancements by key industry players in the treatment of toxicities are further accelerating the market's upward momentum. DelveInsight's Antidote Market Insights report provides the current and forecast market analysis, individual leading antidote companies' market shares, challenges, antidote market drivers, barriers, trends, and key market antidote companies in the market. Key Takeaways from the Antidote Market Report As per DelveInsight estimates, North America is anticipated to dominate the global antidote market during the forecast period. In the antidote type segment of the antidote market, the biological antidotes category accounted for the largest market share in 2024. Notable antidote companies such as Pfizer Inc., SERB Pharmaceuticals, McKesson Corporation, Amneal Pharmaceuticals LLC, EMERGENT, Novartis AG, Troikaa, Hope Pharmaceuticals, Rare Disease Therapeutics, Inc., BTG International Inc., Viatris Inc., Glentham® Life Sciences Limited, Kaleo, Inc., SGPharma Pvt. Ltd., American Regent, Inc., FFF Enterprises, Inc., Amphastar Pharmaceuticals, Inc., Purdue Pharma L.P., Indivior PLC, Harm Reduction Therapeutics, Inc., and several others are currently operating in the antidote market. In August 2024, Purdue Pharma L.P. received FDA approval for the New Drug Application (NDA) of Zurnai™ (nalmefene injection) auto-injector. In March 2024, Indivior PLC announced the results of a pharmacodynamic study showcasing that OPVEE® effectively and rapidly reverses opioid-induced respiratory depression, the primary cause of death in opioid overdoses. This breakthrough demonstrates the potential of OPVEE® as a critical intervention in emergency overdose situations, offering a swift response to prevent life-threatening complications associated with opioid toxicity. To read more about the latest highlights related to the antidote market, get a snapshot of the key highlights entailed in the Global Antidote Market Report Antidote Overview Antidote refers to a substance that counteracts the harmful effects of a poison or toxin. When an individual is exposed to a toxic substance, whether through ingestion, inhalation, injection, or skin contact, an antidote can help neutralize the toxin, reverse its effects, or support the body's natural elimination processes. Antidotes work through various mechanisms: some bind directly to the toxin, others block its biological effects, and some enhance the body's own detoxification systems. Common examples include activated charcoal for many oral poisons, naloxone for opioid overdoses, and atropine for certain nerve agent or pesticide exposures. The development and timely administration of antidotes are crucial in emergency medicine and toxicology. While some antidotes are broadly effective against a wide range of toxins, others are highly specific, targeting a single compound or class of poisons. Due to the diversity of toxic agents and the complexity of their effects on human biology, ongoing research in pharmacology and biochemistry continues to play a critical role in discovering new antidotes. In mass exposure events or cases of rare poisoning, the availability and distribution of appropriate antidotes can be a matter of life and death, underscoring their significance in public health preparedness and clinical Market Insights North America held a substantial share of the antidote market in 2024, fueled by several critical factors. The growing number of poisoning and drug overdose incidents across the region has significantly increased the need for effective antidote solutions. In particular, the opioid epidemic in the United States has driven demand for treatments like naloxone, which can reverse opioid overdoses. Public health campaigns and government-led efforts to curb and manage drug overdoses have further enhanced access to antidotes. Moreover, the market is witnessing a boost from ongoing pharmaceutical innovation and the introduction of new, targeted treatments. In response to this concerning trend, regional authorities have launched various initiatives to address drug overdoses and poisoning. For example, the U.S. Food and Drug Administration (FDA) implemented the Overdose Prevention Framework, which aims to reduce unnecessary opioid prescriptions, encourage harm-reduction strategies through education and innovation, and support the development of evidence-based therapies for substance use disorders and overdoses. Canada is also actively combating the overdose crisis. The Canadian government is investing in prevention programs, expanding access to treatment and harm-reduction services, and leveraging data-driven approaches to guide policy-making. These comprehensive efforts are fostering an environment conducive to the growth of the antidote market across North America. Additionally, pharmaceutical companies in the region are intensifying research and development efforts to bring advanced overdose treatments to market. For instance, in August 2024, Purdue Pharma L.P. received FDA approval for its New Drug Application (NDA) for Zurnai™ (nalmefene injection) auto-injector. This product is designed for emergency use in opioid overdoses caused by both natural and synthetic opioids in adults and adolescents aged 12 and above. The approval of Zurnai™ has expanded the arsenal of available opioid overdose antidotes, offering a fast-acting, user-friendly option to help tackle the ongoing opioid crisis. To know more about why North America is leading the market growth in the antidote market, get a snapshot of the Antidote Market Outlook Antidote Market Dynamics The antidote market is a crucial segment of the global pharmaceutical and toxicology landscape, driven by the increasing incidence of poisoning cases from pharmaceuticals, snake bites, chemical exposure, and overdoses. With growing awareness about drug misuse and rising environmental hazards, the demand for antidotes has surged in both developed and developing countries. Additionally, the rise in hospital admissions due to opioid overdoses, especially in North America and parts of Europe, has directly increased the need for effective and rapid-response antidotes like naloxone. One of the primary market dynamics shaping the antidote sector is the regulatory landscape. Antidotes, often falling under emergency-use drugs, receive fast-track approvals in certain jurisdictions due to their life-saving potential. Governments and healthcare bodies have also begun stockpiling critical antidotes as part of national preparedness programs, especially in regions vulnerable to snake bites or chemical attacks. Furthermore, innovations in biotechnology have allowed the development of more targeted and efficient antidotes, including monoclonal antibodies and small molecule inhibitors tailored for specific toxins or venoms. However, the market faces significant challenges. Many antidotes are expensive to develop and maintain, especially when the target population is small or geographically limited. For example, antivenoms for rare snake species may not be commercially viable due to high R&D costs and limited demand. This has led to a reliance on public-private partnerships and NGO involvement to ensure production and distribution in low-income areas. Moreover, the shelf-life and storage requirements of many antidotes add to supply chain complexity, often limiting their availability in remote or underdeveloped regions. Looking ahead, the antidote market is expected to benefit from increased global focus on public health preparedness and bioterrorism defense. The COVID-19 pandemic underscored the importance of rapid medical response capabilities, prompting governments to revisit their emergency drug inventories. Additionally, as pharmaceutical companies invest in advanced drug delivery systems and synthetic biology, novel antidotes with longer shelf lives and broader efficacy profiles are likely to emerge. The integration of digital health tools and AI in toxicology response systems could also streamline the identification and administration of antidotes, improving patient outcomes and operational efficiency in emergency care. Get a sneak peek at the antidote market dynamics @ Antidote Market Trends Report Metrics Details Coverage Global Study Period 2022–2032 Antidote Market CAGR ~7% Antidote Market Size by 2032 USD 4 Billion Key Antidote Companies Pfizer Inc., SERB Pharmaceuticals, McKesson Corporation, Amneal Pharmaceuticals LLC, EMERGENT, Novartis AG, Troikaa, Hope Pharmaceuticals, Rare Disease Therapeutics, Inc., BTG International Inc., Viatris Inc., Glentham® Life Sciences Limited, Kaleo, Inc., SGPharma Pvt. Ltd., American Regent, Inc., FFF Enterprises, Inc., Amphastar Pharmaceuticals, Inc., Purdue Pharma L.P., Indivior PLC, Harm Reduction Therapeutics, Inc., among others Antidote Market Assessment Antidote Market Segmentation Antidote Market Segmentation By Type: Chemical Antidotes and Biological Antidotes Antidote Market Segmentation By Route of Administration: Oral and Parenteral Antidote Market Segmentation By Distribution Channel: Hospital and Retail Pharmacies Antidote Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the antidote market are set to emerge as the trendsetter explore @ Antidote Companies Table of Contents 1 Antidote Market Report Introduction 2 Antidote Market Executive Summary 3 Competitive Landscape 4 Regulatory Analysis 5 Antidote Market Key Factors Analysis 6 Antidote Market Porter's Five Forces Analysis 7 Antidote Market Layout 8 Antidote Market Company and Product Profiles 9 KOL Views 10 Project Approach 11 About DelveInsight 12 Disclaimer & Contact Us Interested in knowing the antidote market by 2032? Click to get a snapshot of the Antidote Market Analysis Related Reports Heavy Metal Poisoning Market Heavy Metal Poisoning Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key heavy metal poisoning companies, including EmeraMed, Magellan Diagnostics, Bezoloven Inc., among others. Substance Use Disorder Market Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SUD companies including BioXcel Therapeutics, NFL Biosciences, STALICLA, Embera NeuroTherapeutics, PleoPharma, Kinnov Therapeutics, Imbrium Therapeutics, Atai Life Sciences, Beckley Psytech, among others. 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These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. CONTACT: Contact Us Shruti Thakur info@ +14699457679Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Standard
04-06-2025
- Business
- Business Standard
Gland Pharma receives USFDA approval for Angiotensin II Acetate Injection 2.5 mg/mL
Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA of La Jolla Pharma LLC. This Product is indicated for increasing the blood pressure in adults with septic or other distributive shock. Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of approximately USD 58 million for the twelve months ending March 2025.
Associated Press
03-06-2025
- Business
- Associated Press
Affinia Therapeutics and DCM Foundation Announce Partnership to Increase Awareness About BAG3 Dilated Cardiomyopathy and Critical Need for Genetic Testing to Help Save Lives
WALTHAM, Mass. & DUBLIN, Ohio--(BUSINESS WIRE)--Jun 3, 2025-- Affinia Therapeutics ('Affinia'), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, and the DCM Foundation together with the Genetic Cardiomyopathy Awareness Consortium (GCAC), today announced they have joined forces to raise awareness about BAG3 dilated cardiomyopathy (DCM), with the goal of promoting early diagnosis and the critical need for genetic testing. BAG3 DCM is a devastating monogenic heart disease affecting more than 70,000 patients in the U.S., Europe, and U.K. regions alone. The BAG3 gene, or Bcl2-associated athanogene 3, encodes for a protein that is critical to the normal structure and function of heart cells. Patients with BAG3 DCM have a mutation in the BAG3 gene and a deficiency in functional BAG3 protein, resulting in early onset heart failure that progresses rapidly. Despite current standard of care, almost 25% of patients require a heart transplant. According to a study published in Circulation, the journal of the American Heart Association, close to 50% of cardiomyopathy has some type of genetic basis, such as BAG3 DCM, yet only a fraction of diagnosed cardiomyopathy patients get genetic testing. This new-found partnership between Affinia and the DCM Foundation and GCAC aims to educate about BAG3 DCM and the critical need for genetic testing, and champions the needs and voices of people living with this devastating heart disease through initiatives including: 'The DCM Foundation and GCAC are very grateful for this partnership with Affinia,' said Greg Ruf, Founder and Executive Director, the DCM Foundation. 'By getting more cardiomyopathy patients tested, we can potentially save and improve lives and help advance cardiomyopathy research and therapies. Through this collaboration, we will collectively unite our strengths and work together in the hope of making a real difference for those living with this devastating disease.' Hideo Makimura, M.D., Ph.D., Chief Medical Officer of Affinia, commented, 'BAG3 DCM is a devastating heart disease with a known genetic cause. Unfortunately, only a fraction of patients affected with BAG3 DCM and other genetic cardiomyopathies are tested, which is putting lives at risk. We are committed to working together with the DCM Foundation and GCAC to increase disease awareness and the role genetics plays in cardiomyopathy, which we believe will ultimately lead to better outcomes for people living with BAG3 DCM.' 'Our partnership with the DCM Foundation and GCAC is an exciting milestone as we advance our lead program, AFTX-201 for BAG3 DCM, toward an Investigational New Drug submission and clinical trial initiation which are aligned with Affinia's purpose to make a lasting positive impact in the lives of people affected by devastating rare and prevalent diseases where the genetic cause is understood,' said Rick Modi, Affinia's Chief Executive Officer. About Affinia Therapeutics Affinia Therapeutics is pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics' pipeline of first-in-class or best-in-class product candidates in cardiovascular and neurological diseases leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit About DCM Foundation Founded in 2018, the DCM Foundation's mission is to provide hope and support to DCM patients and families with dilated cardiomyopathy through education, research and advocacy. Our mission is being executed through three foundational pillars: information and education, patient and family support, and understanding the need for genetic testing. In 2023, DCMF created the Genetic Cardiomyopathy Awareness Consortium, comprised of 11 patient group members, to address the extreme lack of knowledge about genetics and genetic testing in the cardiomyopathy patient and medical community. For more information, visit and View source version on CONTACT: Media contacts:For Affinia Kathy Vincent [email protected] 310-403-8951For DCM Foundation Buddy Butler [email protected] 304-615-9884 KEYWORD: MASSACHUSETTS OHIO UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH NEUROLOGY GENETICS CARDIOLOGY PHILANTHROPY BIOTECHNOLOGY PHARMACEUTICAL HEALTH FOUNDATION SCIENCE SOURCE: Affinia Therapeutics Copyright Business Wire 2025. PUB: 06/03/2025 07:45 AM/DISC: 06/03/2025 07:44 AM
