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FDA Approves Johnson & Johnson's IMAAVYTM (nipocalimab-aahu) a New Treatment for Myasthenia Gravis (MG), Offering Hope for Families

1. FDA approved JNJ's IMAAVYTM for generalized myasthenia gravis treatment. 2. IMAAVYTM is a first-in-class FcRn inhibitor targeting pathogenic autoantibodies. 3. Approval expands treatment options for over 100,000 U.S. patients with gMG. 4. Current treatments often provide incomplete relief; new therapy offers effective control. 5. Success built on pivotal Vivacity-MG3 study supporting the approval.

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Why Bullish?

The FDA approval enhances JNJ's product portfolio, similar to prior successful drug launches like Remicade and Stelara, which resulted in significant revenue increases and market share growth.

How important is it?

The approval addresses an unmet medical need, potentially increasing JNJ's sales and enhancing its reputation in neurology and autoimmunity.

Why Long Term?

Successful adoption of IMAAVYTM can lead to sustained revenue streams, akin to past introductions of new therapies in chronic disease markets.

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New York, April 30, 2025 (GLOBE NEWSWIRE) -- Muscular Dystrophy Association (MDA) applauds the U.S. Food and Drug Administration (FDA) approval of IMAAVYTM (nipocalimab-aahu) for the treatment of people ages 12 and older who are living with antibody positive (AChR+ or MuSK+) generalized myasthenia gravis (gMG). Learn more about this approval in Johnson & Johnson’s news release here. This milestone marks another significant advancement for the more than 100,000 people living with gMG in the U.S. gMG is a chronic autoimmune neuromuscular disease that leads to muscle weakness and fatigue. IMAAVYTM (nipocalimab-aahu) is a first-in-class FcRn (neonatal Fc receptor) inhibitor, designed to reduce the levels of pathogenic autoantibodies that drive MG. By targeting these autoantibodies, IMAAVYTM (nipocalimab-aahu) offers patients a targeted, effective, and potentially life-changing treatment option. “FDA’s approval of IMAAVYTM (nipocalimab-aahu) is an important step in expanding treatment options for people living with myasthenia gravis,” said Donald S. Wood, PhD, President and CEO, MDA. “With each new therapy, we move closer to more personalized and accessible care, giving people more choices to manage their symptoms and improve their quality of life.” While current treatments exist for gMG, many patients experience incomplete symptom relief or challenging side effects. IMAAVYTM (nipocalimab-aahu) approval expands the treatment landscape, offering a novel approach to reducing disease burden and providing a new option for those who have struggled with conventional therapies. “We applaud this approval alongside our partners in research for the families in the neuromuscular disease community we serve,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA. “MDA remains committed to supporting continued innovation in myasthenia gravis and all rare neuromuscular diseases.” FDA’s approval of IMAAVYTM (nipocalimab-aahu) is supported by data from the pivotal, ongoing Vivacity-MG3 study – the longest primary endpoint of a registrational trial of any FcRn blocker in adults with living with gMG. With this approval, patients will soon have access to a therapy that could provide more effective symptom control and improved daily living. Read more here. Dr. Tahseen Mozaffar, a distinguished neurologist at UCI Health, has significantly contributed to the advancement of treatments for generalized myasthenia gravis (gMG), including the development and clinical evaluation of IMAAVYTM (nipocalimab-aahu). “IMAAVYTM (nipocalimab-aahu) adds another safe option for care and treatment of these patients and enhances the range of FcRN antagonists that are now available to treat myasthenia gravis. These agents have changed how MG is cared for by the physicians,” said Dr. Mozaffar. Since its inception 75 years ago, the organization has funded more than $57 million in myasthenia gravis research. For more information on MG, and ongoing support for families and medical professionals, contact the MDA Resource Center by phone 1-833-ASK-MDA1 (1-833-275-6321) or email ResourceCenter@mdausa.org. Media contact press@mdausa.org. About Muscular Dystrophy AssociationMuscular Dystrophy Association (MDA) is the #1 voluntary health organization in the United States for people living with muscular dystrophy, ALS, and over 300 other neuromuscular conditions. For 75 years, MDA has led the way in accelerating research, advancing care, and advocating support and inclusion of families living with neuromuscular disease. MDA's mission is to empower the people we serve to live longer, more independent lives. To learn more visit mda.org and follow MDA on Instagram, Facebook, X, Threads, Bluesky, TikTok, LinkedIn, and YouTube. About Muscular Dystrophy Association’s 75th AnniversaryIn 2025, the Muscular Dystrophy Association proudly marks 75 years legacy, impact and momentum in the fight against neuromuscular diseases. Since our founding, MDA has been at the forefront of research breakthroughs, providing access to comprehensive care, and championing the rights of people living with muscular dystrophy, ALS, and over 300 other neuromuscular diseases. This milestone has been made possible by generations of dedicated support from people living with neuromuscular disease, their families, researchers, clinicians, volunteers, and donors—who boldly drive our mission forward. As we look ahead, we remain committed to honoring this legacy, building on the impact we’ve made together, and continuing our momentum toward transformative progress for people living with neuromuscular disorders. Learn more at MDA75.org. FDA Approves New Treatment for Generalized Myasthenia Gravis FDA Approves New Treatment for Generalized Myasthenia Gravis FDA Approves Johnson & Johnson’s IMAAVYTM (nipocalimab-aahu) a New Treatment for Myasthenia Gravis (...

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