J&J presents two-year IMAAVY data in adolescent myasthenia gravis

Johnson & Johnson (NYSE: JNJ) announced new data on IMAAVY (nipocalimab-aahu) for generalized myasthenia gravis (gMG), including two-year results from a Phase 2/3 adolescent study, to be presented at the 2026 Myasthenia Gravis Foundation of America Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting.

The Vibrance-MG Phase 2/3 long-term extension study enrolled seven adolescents aged 12-17 with anti-acetylcholine receptor positive gMG. At Week 108, participants showed mean changes from baseline of -2.88 points on the Myasthenia Gravis Activities of Daily Living scale and -8.25 points on the Quantitative Myasthenia Gravis scale, consistent with results measured at Week 4, Week 24, and intervening time points. Of six adolescent patients taking corticosteroids at study entry, three reduced their dose and one discontinued after two years. No new safety signals were identified through two years of treatment.

A separate retrospective survey of U.S. neurology healthcare providers covering 97 adult gMG patients who switched to IMAAVY from prior advanced therapies found that fluctuating symptom control was cited as the reason for discontinuing prior therapy in 54.6% of cases. Healthcare providers cited preference for a consistent treatment schedule (62.9%) and hope for improved efficacy (56.7%) as the primary reasons for initiating IMAAVY. Following the transition, 73.2% of patients were reported as "much improved" or "very much improved," while 76.4% of patients receiving prednisone reduced their dose and 5.5% discontinued it. The survey relied on retrospective medical record review and healthcare provider reporting, which may be subject to recall and information bias.

IMAAVY is currently approved by the U.S. Food and Drug Administration and the European Medicines Agency for gMG in adults and pediatric patients 12 years of age and older who are anti-AChR or anti-MuSK antibody positive. The drug is also approved for warm autoimmune hemolytic anemia in patients 12 and older. The findings are based on a company press release and data presented at a medical conference.

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