Johnson & Johnson wins European Commission approval for IMAAVY (nipocalimab) in generalized myasthenia gravis
Reuters
3 hours ago
Johnson & Johnson wins European Commission approval for IMAAVY (nipocalimab) in generalized myasthenia gravis
Johnson & Johnson has received European Commission approval for IMAAVY® (nipocalimab), a new FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). This approval covers a broad population, including adults and adolescents aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive. Nipocalimab is the first FcRn blocker approved for both adult and adolescent gMG patients in Europe, and is already approved in the U.S., Brazil, and Japan for this indication. The decision is supported by data from phase 2/3 clinical studies demonstrating sustained disease control and favorable tolerability in both adult and adolescent populations.
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