Announcement of New gMG Study from Johnson & Johnson

Johnson & Johnson Launches New Studies with IMAAVY™ for gMG

Johnson & Johnson (NYSE: JNJ) has announced plans to initiate the first direct comparison study for patients with generalized myasthenia gravis (gMG). This study aims to compare the treatment of IMAAVY™ (nipocalimab-aahu) with efgartigimod. The study, called EPIC, is designed to include treatment transition arms for patients.

New data show that the treatment with IMAAVY™ has resulted in a sustainable reduction of immunoglobulin G (IgG) over 72 weeks in pediatric patients, demonstrating significant improvements in disease control. IMAAVY™ is the only FcRn blocker for both adult and pediatric patients with anti-AChR and anti-MuSK antibody positive gMG, proving to provide sustainable disease control.

The EPIC study will be a randomized, open-label study to compare FcRn blockers in adult gMG patients. This study will evaluate whether IMAAVY™ provides disease control in patients treated with efgartigimod. Primary endpoints include changes in total IgG levels 8-12 weeks after treatment initiation and sustainable disease control.

Leonard L. Dragone, M.D., Ph.D., noted that this study represents a significant advancement in the care of individuals living with gMG. By directly comparing IMAAVY™ to another FcRn blocker, this study aims to guide real-world clinical decisions, strengthening the most effective treatment strategies.

The Vibrance-MG study conducted for pediatric patients has shown that treatment with IMAAVY™ provides sustainable IgG reduction, disease control, and functional improvements throughout the 72-week period. These results offer an important treatment option for pediatric patients with gMG who do not respond adequately to standard therapies.

The results support the positive and sustainable outcomes of the Vibrance-MG study. New data reveal that IMAAVY™ provides rapid and sustainable reductions in IgG levels. Dr. Jonathan Strober expressed that treatment options have long been limited in gMG research for pediatric patients, and these data have significant potential to provide long-term disease control for pediatric patients.

IMAAVY™ has been approved by the U.S. Food and Drug Administration for patients with anti-AChR or anti-MuSK antibody positive gMG. The developing company is Janssen Biotech, Inc., and approval applications for gMG treatment are ongoing worldwide.