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)

Core Insights - The U.S. FDA has approved IMAAVY™ (nipocalimab-aahu), the first and only FcRn blocker for treating generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 and older who are anti-AChR or anti-MuSK antibody positive [1][4][11] - IMAAVY has shown rapid and substantial reduction in immunoglobulin G (IgG) levels, leading to lasting disease control and symptom relief for up to 20 months in pivotal studies [1][3][4] - The approval is supported by data from the ongoing Vivacity-MG3 study, which is the longest primary endpoint of a registrational trial for any FcRn blocker in adults with gMG [1][8] Company Overview - Johnson & Johnson is committed to providing affordable access to IMAAVY through a patient support program, allowing commercially insured patients to receive their first treatment quickly and at minimal cost [4][23] - The company has a strong focus on innovative medicine and aims to address significant unmet needs in the treatment of autoantibody diseases [4][23] Industry Context - gMG is a chronic, debilitating autoantibody disease affecting approximately 700,000 people worldwide, with a significant unmet need for effective therapies [7][8] - The approval of IMAAVY represents a significant advancement in the treatment landscape for gMG, particularly for the 90% of patients who are anti-AChR or anti-MuSK antibody positive [1][4][7] - Ongoing studies, including the Vibrance Phase 2/3 pediatric study, are further evaluating the efficacy and safety of IMAAVY in younger populations [2][9]