EC approval of J&J’s Imaavy in gMG

2 December 2025

US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission has approved a marketing authorization for Imaavy (nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG).

This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients aged 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody-positive.

Anti-AChR and anti-MuSK antibody-positive individuals comprise at least 90% of the total antibody-positive gMG population.

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