Nipocalimab Receives Priority Review From FDA Based on Phase III Vivacity-MG3 Trial Results

Image Credit: Adobe Stock Images/Lila Patel

The FDA has granted priority review to Johnson & Johnson’s nipocalimab for the treatment of generalized myasthenia gravis (gMG). This action is supported by positive results from the Phase III Vivacity-MG3 clinical trial in which nipocalimab demonstrated superiority in activities of daily living (MG-ADL) over placebo when added to standard of care (SOC).¹

In a press release, Katie Abouzahr, MD, vice president, autoantibody portfolio and maternal fetal immunology disease area leader at Johnson & Johnson Innovative Medicine said, "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. We are committed to working closely with the FDA to help bring nipocalimab as a potential treatment to certain patients living with gMG, and we especially thank the participants in the Phase II and III studies. If approved, nipocalimab has the potential to treat gMG in antibody positive individuals, including anti-AChR, anti-MuSK, and/or anti-LRP4."

Results from the Phase III Vivacity-MG3 study were announced by Johnson & Johnson earlier in June 2024. In the trial, patients treated with nipocalimab plus SOC achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. The full results of the study were presented at the European Academy of Neurology (EAN) 2024 Congress.²

The double-blind placebo-controlled study identified 199 patients, of which 153 were antibody positive, and enrolled. These participants were randomized 1:1 to receive either nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC. In addition to the primary endpoint of improvement in MG-ADL score, a key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score.

In a press release from the time, Carlo Antozzi, MD, neuroimmunology and muscle pathology unit of the Neurological Institute Foundation C. Besta of Milan, Italy said, “The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis. We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis.”

Abouzahr added, “We are thrilled to present yet another dataset for nipocalimab at the EAN 2024 Annual Meeting highlighting our commitment to providing innovative treatments for autoantibody-driven diseases. We are developing transformative therapies that have the potential to address significant unmet patient need.”

Additionally, Johnson & Johnson has submitted a Marketing Authorization Application (MAA) to EMA for the approval of nipocalimab in gMG. Nipocalimab has also received FDA Breakthrough Therapy Designation for the treatment of adults with moderate-to-severe Sjögren's disease based on results from the Phase II DAHLIAS study.

References

1. Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis. News release. Johnson & Johnson. January 9, 2025. Accessed January 9, 2025. https://www.prnewswire.com/news-releases/nipocalimab-granted-us-fda-priority-review-for-the-treatment-of-generalized-myasthenia-gravis-302346976.html?tc=eml_cleartime

2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. News release. Johnson & Johnson. June 28, 2024. Accessed January 9, 2025. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class