SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) has announced promising results from its pivotal Phase 3 Vivacity-MG3 study evaluating nipocalimab, an investigational FcRn blocker, for generalized myasthenia gravis (gMG). Data published in The Lancet Neurology reveal significant strides in managing this rare and debilitating autoantibody-driven disease, impacting an estimated 700,000 people globally.
The study demonstrated that nipocalimab achieved a statistically significant improvement in MG-ADL scores over 24 weeks, with responders experiencing a 2-point or greater reduction. Notably, the drug reduced autoantibody levels—one of the key drivers of gMG—by up to 75%, while maintaining a tolerable safety profile comparable to placebo. These findings establish nipocalimab as the first FcRn blocker to sustain disease control across a broad population of antibody-positive adults.
“Nipocalimab has been shown in multiple clinical studies to help reduce IgG, including autoantibodies, among this broad population of antibody positive adults with gMG,” said Dr. Carlo Antozzi, Neuroimmunology and Muscle Pathology Unit at the Neurological Institute Foundation C. Besta in Milan, Italy. He added, “It’s promising to see this positive data published in The Lancet Neurology as there is a continued need for additional approved targeted therapies with demonstrated safety profiles that offer sustained disease control for a broad range of antibody positive patients living with gMG.”
Beyond its clinical efficacy, nipocalimab’s safety profile saw adverse event discontinuation rates of 5.1%, similar to 7.1% recorded in the placebo group. These results support its potential to provide meaningful disease management while preserving immune protection, a critical factor in treating autoantibody conditions.
“The Phase 3 Vivacity-MG3 data demonstrates our steadfast pursuit of researching and developing potential innovative and transformational approaches for autoantibody-driven diseases, such as gMG,” said Dr. Sindhu Ramchandren, Executive Medical Director, Neuroscience, Johnson & Johnson Innovative Medicine. “We are delighted by the publication of this robust Phase 3 data in The Lancet Neurology as well as the Priority Review granted by the FDA. People living with gMG require additional effective immunoselective therapeutic options that can potentially preserve the ability to maintain a protective immune response even after reduction of IgG.”
The investigational therapy has been granted Priority Review by the U.S. FDA, signaling its potential to address significant unmet needs in gMG care. Additionally, applications for regulatory approvals have been submitted to the FDA and European Medicines Agency (EMA), with decisions anticipated in the coming months.
If approved, nipocalimab could become a critical tool for improving quality of life for those affected by gMG, offering new hope in the ongoing fight against this chronic and life-altering disease.
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