J&J(US:JNJ) Prnewswire·2025-06-23 11:32Core Insights - Johnson & Johnson announced new data from an indirect treatment comparison (ITC) showing that IMAAVY (nipocalimab-aahu) provides consistent and sustained disease control in adults with generalized myasthenia gravis (gMG) compared to other approved FcRn blockers [1][2][4] Company Overview - IMAAVY received U.S. FDA approval for a broad population of gMG patients, including those who are anti-AChR and anti-MuSK antibody positive, as well as pediatric patients aged 12 and older [1][4] - The company is committed to helping patients with chronic autoantibody conditions and continues to research the potential impact of IMAAVY [4][10] Treatment Efficacy - The ITC included data from the pivotal Phase 3 Vivacity-MG3 study, demonstrating that IMAAVY showed comparable onset of symptom relief at Week 1 and statistically significant improvements in MG-ADL scores at multiple timepoints up to 24 weeks [2][5][9] - IMAAVY exhibited significantly greater mean improvements in MG-ADL scores compared to other FcRn blockers, with notable differences observed at Weeks 8-24 [5][8] Regulatory and Market Position - IMAAVY is approved in the U.S. for adult and pediatric patients with gMG, and a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for approval in Europe [4][10] - The ITC methodology used in the analysis adheres to global health technology assessment standards, providing valuable comparative data for regulatory agencies and medical guideline committees [4][7] Patient Population and Disease Context - Myasthenia gravis affects an estimated 700,000 people worldwide, with approximately 100,000 individuals in the U.S. living with gMG [6][9] - The disease predominantly affects women and can manifest in pediatric patients, with a significant portion of cases diagnosed in girls [6][9]