Johnson & Johnson has announced the submission of a Marketing Authorisation Application $(MAA)$ to the European Medicines Agency $(EMA)$ for the approval of nipocalimab, marketed as IMAAVY™, for the treatment of generalized myasthenia gravis (gMG). This submission, made in September 2024, seeks to expand the use of IMAAVY, an FcRn blocker, which has already received U.S. FDA approval for a broad range of gMG patients, including those with anti-AChR and anti-MuSK antibodies, aged 12 and older. The application is part of Johnson & Johnson's efforts to provide consistent and sustained disease control for individuals living with this chronic autoantibody disease.
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