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BioWorld - Friday, March 6, 2026
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Home » With FDA approval, J&J enters the myasthenia gravis fray
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With FDA approval, J&J enters the myasthenia gravis fray

April 30, 2025
By Lee Landenberger
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The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
BioWorld Regulatory Immune Monoclonal antibody U.S. FDA

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