SPRING HOUSE, PA — The U.S. Food and Drug Administration (FDA) has granted Priority Review to Johnson & Johnson’s Biologics License Application (BLA) for nipocalimab, a treatment for generalized myasthenia gravis (gMG) in antibody-positive patients, including those with anti-AChR, anti-MuSK, and anti-LRP4 antibodies.
The Priority Review designation applies to therapies that offer a significant improvement over current treatment options for serious medical conditions. This signals the FDA’s recognition of nipocalimab’s potential to address unmet needs among people living with gMG, a chronic autoimmune disease that impacts around 700,000 individuals worldwide.
The application is supported by findings from the Phase 3 Vivacity-MG3 study, which demonstrated sustained disease control over 24 weeks in a diverse group of antibody-positive patients. Results show that the treatment, combined with the standard of care, significantly improved the Myasthenia Gravis Activities of Daily Living score (MG-ADL), a key measure of patient functionality. Improvements were meaningful, marking a positive difference in critical everyday activities, such as swallowing or breathing.
“We welcome the FDA’s decision to grant Priority Review for the treatment of generalized myasthenia gravis, which underscores the need for additional treatment options in a broad population of people living with gMG,” said Katie Abouzahr, M.D., Vice President of Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine.
gMG, which is both rare and life-long, is driven by autoantibodies that disrupt communication between nerves and muscles, leading to muscle weakness and fatigue. Currently, there is no cure for the condition, and treatment advancements are critical to improving patient quality of life.
Beyond the U.S., Johnson & Johnson has also submitted a Marketing Authorisation Application for nipocalimab to the European Medicines Agency. Additionally, the drug has received Breakthrough Therapy Designation from the FDA for addressing moderate-to-severe Sjögren’s disease, further expanding its potential footprint in addressing autoantibody-driven illnesses.
If approved, nipocalimab could provide a new standard of care for patients with gMG, complementing existing therapies and giving hope to a community seeking better treatment options. This marks a significant step forward in Johnson & Johnson’s commitment to innovation in autoimmune and immunological disorders.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.