Johnson & Johnson Reports Positive Long-Term Results for Nipocalimab in Generalized Myasthenia Gravis

Johnson & Johnson announced encouraging new data from the Phase 3 Vivacity-MG3 study and its open-label extension evaluating nipocalimab for the treatment of generalized myasthenia gravis (gMG). The findings show sustained improvements in patient symptoms and reduced immunoglobulin G (IgG) antibody levels over an 18-month period.

Key highlights include:
- Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in muscle strength and daily function, with results sustained for up to 84 weeks, and in some cases, up to 128 weeks.
- A significant proportion (45%) of patients using steroids at the start of the open-label phase were able to reduce or discontinue their steroid dosage.
- During the 24-week double-blind phase, patients receiving nipocalimab were four times more likely to maintain improvement in muscle strength (as measured by QMG scores) than those on placebo.

Nipocalimab also demonstrated a favorable safety profile throughout the trial phases. The company presented these findings at the American Academy of Neurology (AAN) 2025 Meeting, underscoring the potential of nipocalimab as a long-term treatment option for gMG.

The investigational monoclonal antibody targets the FcRn receptor to reduce circulating IgG autoantibodies. It has received multiple designations from the FDA and EMA, including Fast Track, Orphan Drug, Breakthrough Therapy, and Priority Review for various autoimmune and maternal-fetal conditions.

The study strengthens Johnson & Johnson’s positioning in the autoantibody disease space and supports ongoing efforts to bring new, durable treatments to patients with chronic, debilitating diseases like gMG.