CHMP recommends approval of J&J's nipocalimab for myasthenia gravis

Published: 2025-09-19 10:54:11 ET JNJ

Published on 09/19/2025 at 10:54 am EDT

Johnson & Johnson announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion recommending the approval of nipocalimab in the European Union (EU) as a treatment for generalized myasthenia gravis (gMG).The CHMP's positive opinion covers a broad population of adults and adolescents aged 12 years and older with antibodies to the acetylcholine receptor (AChR) or muscle tyrosine kinase (MuSK).Generalized myasthenia gravis is a rare, chronic autoimmune disease in which IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.According to J&J, it affects between 56,000 and 123,000 people in Europe.