SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) announced plans to launch the first-ever head-to-head study comparing its FcRn blocker IMAAVY™ (nipocalimab-aahu) with efgartigimod in adults living with generalized myasthenia gravis (gMG).
The Phase 3b EPIC trial will evaluate whether IMAAVY delivers superior disease control to efgartigimod among patients who have not previously received an FcRn blocker. The study will also feature a treatment-switch arm to examine outcomes for patients transitioning from efgartigimod to IMAAVY. Researchers will track changes in total immunoglobulin G (IgG) levels and sustained disease control using validated Myasthenia Gravis assessment scales.
“The EPIC study marks an important step forward in advancing care for people living with gMG,” said Dr. Leonard L. Dragone, Disease Area Leader for Autoantibody and Rheumatology at Johnson & Johnson Innovative Medicine. “By directly comparing IMAAVY to another FcRn blocker and incorporating a treatment-switch arm, EPIC will provide critical insights to help guide clinical decisions and strengthen confidence in treatment strategies.”
The company also unveiled new long-term data from the Vibrance-MG Phase 2/3 pediatric study. Pediatric patients aged 12 and older who received IMAAVY with standard care experienced sustained IgG reductions of roughly 73% by week 24, along with consistent improvements in muscle strength and daily functioning through 72 weeks. The treatment was generally well tolerated, with no new safety concerns identified during the extended follow-up period.
IMAAVY is the only FcRn blocker approved for adult and pediatric patients aged 12 and older who are anti-AChR or anti-MuSK antibody positive. It is approved in the United States, Brazil, and Japan, with regulatory submissions under review in multiple other markets.
Myasthenia gravis affects an estimated 700,000 people worldwide and is marked by muscle weakness that can severely impact speech, swallowing, and mobility. Pediatric cases represent roughly 10–15% of new diagnoses, with girls comprising a majority of these cases.
Johnson & Johnson’s latest developments in gMG research reflect its growing focus on autoimmune and rare diseases. The company’s IMAAVY program has received several U.S. FDA designations, including Fast Track, Orphan Drug, and Breakthrough Therapy status for multiple autoimmune and maternal-fetal conditions.
The company’s data and trial details will be presented at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session.
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