CHMP Issues Favorable Opinion for FcRn Blocker Nipocalimab as Myasthenia Gravis Treatment

According to a recent announcement, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive recommendation for the approval of nipocalimab (Johnson & Johnson), an FcRn-blocking monoclonal antibody, as an add-on to standard therapy of generalized myasthenia gravis (gMG).¹

If approved, nipocalimab would become the first FcRn blocker for both adult and adolescent gMG populations who are anti-acetylcholine (AChR) or anti-muscle specific kinase (MuSK) antibody-positive. The therapy, which gained FDA approval in April, is supported by data from the ongoing phase 3 Vivacity-MG3 study (NCT04951622), as well as supplemental findings from the phase 2/3 Vibrance-MG study (NCT05265273).

Vivacity-MG3, the most notable trial in nipocalimab’s program, comprised 199 adult patients with antibody positive or negative gMG who had insufficient response to ongoing standard-of-care (SOC) therapy. After 24 weeks of treatment, those randomly assigned to nipocalimab plus current SOC demonstrated a 4.70-point improvement in Myasthenia Gravis-Activities of Daily Living (MG-ADL), the primary end point, compared with improvements of 3.25 points for the placebo plus SOC group (P = .002).²

Additional data from Vivacity-MG3 revealed that treatment with nipocalimab plus SOC led to significant improvements in Quantitative Myasthenia Gravis (QMG) score, a secondary end point, over placebo through weeks 22 and 24 (P <.001). Encouragingly, between the 2 observed groups, there were a similar incidence of adverse events (AEs), serious AEs, and AEs that led to discontinuation.

"Results from the Phase 3 Vivacity-MG3 trial demonstrate nipocalimab has the potential to offer sustained disease control in a condition that is associated with fluctuations in symptoms," Mark Graham, senior director, Therapeutic Area Head, Immunology, at Johnson & Johnson Innovative Medicine EMEA, said in a statement.¹ "Today’s positive CHMP opinion is a vital step forward in our unwavering commitment to improve the treatment landscape for people living with generalized myasthenia gravis across Europe. We look forward to the European Commission’s decision, which brings us closer to delivering an innovative treatment option to those who need it most."

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In Vivacity-MG3, patients in the nipocalimab group were 4 times more likely to sustain symptom improvement at 20 weeks compared with the placebo group, as measured by a 3 or greater point improvement in QMG score. Furthermore, 36.4% of patients in the nipocalimab group spent greater than 75% of study duration demonstrating improvements in QMG score vs 10.5% of those in the placebo group (P <.001).³

In the open-label extension (OLE) of Vivacity-MG3, nipocalimab demonstrated a mean change in MG-ADL of –5.64 (P <.001) from the double-blind baseline after 60 weeks for those who continued on nipocalimab and OSC. For those who transitioned from placebo and SOC to nipocalimab and SOC, the mean change was –6.01 (P <.001).

In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose. Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day.

Vibrance-MG, the trial before Vivacity-MG3, comprised 7 adolescents aged 12-18 with seropositive gMG who received nipocalimab as a 30 mg/kg intravenous loading dose followed by a 15 mg/kg IV every 2 weeks. In this 24-week study, 5 patients completed treatment, showing a mean 69% reduction in serum IgG and clinically meaningful improvements in MG-ADL (–2.4) and QMG (–3.8). Notably, 4 of 5 patients achieved minimal symptom expression, with MG-ADL scores of 0-1.⁴

REFERENCES
1. Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG). News release. Johnson & Johnson. September 19, 2025. Accessed October 1, 2025. https://www.globenewswire.com/news-release/2025/09/19/3153183/0/en/Johnson-Johnson-receives-positive-CHMP-opinion-of-nipocalimab-to-treat-a-broad-population-of-antibody-positive-patients-living-with-generalised-myasthenia-gravis-gMG.html
2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. News Release. Published June 28, 2024. Accessed October 1, 2025. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class
3. Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG). News release. Johnson & Johnson. April 8, 2025. Accessed October 1, 2025.
4. Strober J, Black S, Ramchandren S, et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label phase 2/3 Vibrance-MG clinical study. Presented at: 2024 AANEM Annual Meeting; October 15-18; Savannah, GA.