Johnson & Johnson  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for nipocalimab, an investigational treatment for generalized myasthenia gravis (gMG). This submission marks a significant milestone as the first global regulatory filing for nipocalimab, aimed at providing a novel therapeutic option for patients living with this chronic autoimmune condition.

The application is underpinned by data from the Phase 3 Vivacity-MG3 clinical program, which is the first and only study of its kind to demonstrate sustained disease control over 24 weeks in a broad population of antibody-positive gMG patients, including those with anti-AChR+, anti-MuSK+, and anti-LRP4+ antibodies. These subtypes represent approximately 95% of the gMG patient population. Results showed that patients receiving nipocalimab in combination with standard of care (SOC) exhibited superior outcomes compared to those receiving placebo plus SOC, with significant improvement in MG-ADL scores.

"We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalized myasthenia gravis, a chronic, life-long disease," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "The filing for approval of nipocalimab represents an important step forward as Johnson & Johnson continues to push the boundaries of research to develop innovative solutions to treat autoantibody-driven diseases, building on decades of expertise in neuroscience and immunology. We look forward to working with the FDA in their review of the data supporting the submission."

Nipocalimab is a first-in-class FcRn blocker that binds with high affinity and specificity to reduce levels of pathogenic IgG autoantibodies, which are implicated in diseases like gMG. The Vivacity-MG3 study is notable for its robust design, including the longest period of controlled safety and efficacy assessment of an FcRn blocker in gMG to date. The data presented earlier this year at the American Academy of Neurology Annual Meeting highlighted nipocalimab’s molecular properties, which differentiate it within its class and underscore its potential as a transformative treatment for autoantibody-driven diseases.

Johnson & Johnson is committed to advancing therapies for autoimmune conditions, and the FDA's review of nipocalimab's BLA will be a critical step in potentially bringing this innovative treatment to patients in need.