Nipocalimab-aahu has been approved to treat both adult and pediatric patients with generalized myasthenia gravis who are acetylcholine receptor– or muscle-specific kinase antibody–positive.
The FDA has approved Imaavy (nipocalimab-aahu), a neonatal Fc receptor (FcRn)–blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 years or older who are anti–acetylcholine receptor– (AChR) or anti–muscle-specific kinase (MuSK) antibody–positive. The approval, granted following Priority Review, makes nipocalimab the first FcRn blocker indicated for both AChR+ and MuSK+ gMG populations across adult and adolescent age groups.
gMG is a chronic autoimmune neuromuscular disorder characterized by fluctuating muscle weakness and impaired neuromuscular transmission. AChR+ and MuSK+ patients comprise at least 90% of the antibody-positive gMG population. Nipocalimab is designed to reduce pathogenic IgG autoantibodies without affecting other components of adaptive or innate immunity.
Approval was supported by data from the phase 3 Vivacity-MG3 trial, a 24-week, randomized, placebo-controlled study in adult patients with gMG and an MG-ADL score of at least 6 despite standard-of-care (SOC) therapy. Patients receiving nipocalimab plus SOC achieved significantly greater improvements in MG-ADL scores compared with those receiving placebo, along with a sustained reduction in circulating immunoglobulin G (IgG) levels by up to 75% from baseline. Benefits in disease control and functional improvement—including chewing, swallowing, and breathing—were maintained through 20 months of follow-up in the ongoing open-label extension.
In the ongoing phase 2/3 Vibrance-MG study of adolescents with antibody-positive gMG, treatment with nipocalimab plus SOC resulted in a 69% reduction in total serum IgG over 24 weeks. Secondary endpoints in the pediatric study also showed improvements in MG-ADL and QMG scores after receipt of nipocalimab.
Safety and tolerability of the agent were comparable between adult and pediatric cohorts; the most commonly reported adverse events were upper respiratory tract infection, peripheral edema, and muscle spasms.
Johnson & Johnson has indicated plans for further regulatory submissions for nipocalimab globally and offers a patient support program to facilitate access to therapy. Nipocalimab continues to be evaluated across additional indications involving IgG-mediated autoimmune and alloimmune diseases.
Source: Johnson & Johnson
