January 23, 2025: “Johnson & Johnson announced The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational FcRn blocker, evaluated in a broad population of antibody positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).
The Vivacity-MG3 study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement over 24 weeks in the MG-ADL score.
Nipocalimab had a tolerable safety profile, with adverse events leading to discontinuation rates similar to placebo (5.1% with nipocalimab vs. 7.1% with placebo).
“Nipocalimab has been shown in multiple clinical studies to help reduce IgG, including autoantibodies, among this broad population of antibody positive adults with gMG.
The positive results from the Vivacity-MG3 study further support the potential of nipocalimab to address the underlying cause of this debilitating autoantibody disease,” said Carlo Antozzi, M.D., Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta of Milan, Italy.
“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.”
gMG is a chronic, life-long, rare, autoantibody-driven disease, for which there currently is no cure. gMG impacts an estimated 700,000 people worldwide.
Nipocalimab, a fully human IgG1 antibody, is an immunoselective investigational therapy that has been shown in clinical trials to lower immunoglobulin G (IgG), including pathogenic IgG, one of the root causes of autoantibody diseases.
Data from the Phase 3 study showed up to a 75% reduction in the median pre-dose total IgG from baseline. Additionally, reduction in levels of common pathogenic IgG subclasses, including AChR antibody and MuSK antibody, was observed over 24 weeks of the study.
No changes were observed in total IgE, IgA, and IgM, highlighting the potential ability to maintain a protective immune system even after reduction of pathogenic IgG autoantibodies is observed.
Nipocalimab plus SOC demonstrated a significantly greater reduction in MG-ADL response (≥2-point improvement from baseline) compared with placebo plus SOC (p=0.0213).
For someone living with gMG, a 1- to 2-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and requiring the assistance of a ventilator.
“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 Sindhu Ramchandren, M.D., 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.”
Johnson & Johnson submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG on August 29 and September 11, 2024, respectively.
Nipocalimab was granted Priority Review by the FDA which was supported by findings from the Phase 3 Vivacity-MG3 study.
In addition, nipocalimab recently received U.S. FDA Breakthrough Therapy Designation for the treatment of adults with moderate-to-severe Sjögren’s disease as supported by results from the Phase 2 DAHLIAS study.
