Expanding Myasthenia Gravis Treatment With Newly Approved Therapy Nipocalimab: Nicholas J. Silvestri, MD, FAAN

WATCH TIME: 4 minutes

"We've had a really fantastic time in the field of myasthenia gravis (MG) for over the past 10 years, with multiple medications approved, and I was very happy that we have yet another medication that broadens our ability to treat patients with MG and hopefully allows us to get [the disease better under control in more patients]. "

Nipocalimab (Imaavy; Johnson & Johnson’s), an FcRn blocking therapy, was recently approved as a new treatment by the FDA for adults and pediatric patients aged 12 years and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.¹ The approval, which came in late April, was supported by data from the ongoing, double-blind, placebo-controlled, phase 3 VIVACITY-MG3 study (NCT04951622), which compared patients with MG treated with nipocalimab plus current standard-of-care (SOC) therapy against those treated with placebo plus current SOC.

Findings from the trial showed a 4.70-point improvement in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score, the primary end point, for those on nipocalimab. In comparison, this was significantly more than the 3.25-point improvement from baseline observed in the placebo plus SOC group over weeks 22, 23, and 24 (P = .002). Additionally, those on nipocalimab plus SOC demonstrated a significant improvement in Quantitative Myasthenia Gravis (QMG) score, a secondary end point, over placebo through weeks 22 and 24 (P <.001). These data were also coupled with enhancements in strength and function of different muscle groups.²

Following the approval, Nicholas J. Silvestri, MD, FAAN, a professor of neurology at the University of Buffalo Jacobs School of Medicine and Biomedical Sciences, had a conversation with NeurologyLive^® to discuss the significance of the newly approved therapy. In the discussion, he highlighted its clinical benefits demonstrated in the phase 3 VIVACITY-MG3 trial and noted its unique advantage in treating adolescents, filling an unmet need in that population. In the interview, Silvestri also addressed important considerations such as infection risk, long-term safety, and vaccine administration during treatment, underlining the importance of individualized care and expanding therapeutic choices.

REFERENCES
1. Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG). News release. Johnson & Johnson. April 30, 2025. Accessed May 5, 2025. https://www.prnewswire.com/news-releases/johnson--johnson-receives-fda-approval-for-imaavy-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg-302442650.html
2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. News Release. Published June 28, 2024. Accessed May 5, 2025. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class