Johnson & Johnson receives European Commission approval of IMAAVY® (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG)

Core Insights - Johnson & Johnson has received European Commission approval for IMAAVY® (nipocalimab), the first FcRn blocker for treating generalized myasthenia gravis (gMG) in adults and adolescents aged 12 and older who are anti-AChR or anti-MuSK antibody-positive [1][2] - Nipocalimab has shown significant efficacy in clinical trials, demonstrating rapid and substantial reduction in immunoglobulin G levels, leading to sustained disease control for up to 20 months [1][5] - The approval addresses a significant unmet need in the treatment of gMG, a chronic autoimmune disease affecting an estimated 56,000 to 123,000 people in Europe [2][4] Company Overview - Johnson & Johnson is positioned as a leader in healthcare innovation, focusing on developing treatments for complex diseases, including autoimmune conditions like gMG [10] - The company has previously secured approvals for nipocalimab in the U.S., Brazil, and Japan, with ongoing submissions for regulatory review in other regions [2][8] Industry Context - Generalized myasthenia gravis (gMG) is characterized by debilitating symptoms such as muscle weakness and difficulty in daily activities, impacting a significant population globally [4][5] - The introduction of nipocalimab represents a major advancement in therapeutic options for gMG, particularly for antibody-positive patients, who make up over 90% of the gMG population [1][4] - The ongoing clinical studies, including the Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-MG studies, provide robust data supporting the efficacy and safety of nipocalimab [5][7]