SPRING HOUSE, PA — On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & Johnson’s cutting-edge FcRn-blocking antibody treatment for generalized myasthenia gravis (gMG). This approval makes IMAAVY the first and only FcRn blocker available for adults and pediatric patients aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
gMG is a rare, debilitating autoimmune disease that affects essential daily functions like chewing, speaking, and breathing. With significant unmet treatment needs, the approval of IMAAVY offers renewed hope to patients and families navigating an unpredictable and physically taxing condition.
IMAAVY demonstrated promising results in clinical trials. Data from the pivotal Vivacity-MG3 study showed that patients experienced rapid and substantial reductions in immunoglobulin G (IgG)—one of the disease’s root causes. Over a 24-week period, the treatment improved disease control and daily functioning, with benefits sustained for up to 20 months in an ongoing open-label study. Pediatric results also impressed, with a 69% reduction in IgG levels observed in adolescent patients during the Vibrance Phase 2/3 trial.
“We consistently hear from individuals living with myasthenia gravis who are hopeful for new treatment options that may help bring greater stability, independence and predictability to their lives,” said Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America. “Today’s announcement provides another option which could help address the constant uncertainty and heavy physical and mental toll that MG symptom relapse presents to patients and their families.”
Dr. Nicholas J. Silvestri, Professor of Neurology at the University of Buffalo, added, “The clinical results we’ve seen with IMAAVY represent a significant milestone in the treatment of gMG. Patients experienced substantial symptom relief and lasting disease control that translated into better daily function and did not fade over 24 weeks in the pivotal Vivacity-MG3 study. Having a treatment that delivers this level of durable symptom stability is a meaningful step forward for managing a complex and unpredictable disease like gMG.”
IMAAVY boasts a strong safety profile across both adult and pediatric populations, making it a reliable option for a broad spectrum of patients. Johnson & Johnson is also ensuring affordable access through its IMAAVY withMe program, which provides support for insurance navigation and financial assistance.
David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson, remarked, “Today’s FDA approval of IMAAVY marks a historic milestone for the more than 240 million patients suffering with autoantibody diseases, many with few or no approved targeted treatments. This approval is the result of years of scientific commitment, collaboration, and determination for our nipocalimab program, and we’re proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.”
With regulatory submissions under review in numerous countries, Johnson & Johnson continues its mission to expand access to innovative treatments for patients worldwide.
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