Johnson & Johnson Seeks FDA Approval for Nipocalimab in Generalized Myasthenia Gravis
First FDA submission of nipocalimab is based on positive results from the Phase III Vivacity-MG3 program.
Johnson & Johnson has announced the submission of a Biologics License Application (BLA) to the FDA for nipocalimab. This would mark the investigational therapy’s first approval for the treatment of people living with generalized myasthenia gravis (gMG). The submission includes data from the Phase III Vivacity-MG3 trial.1
"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," Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine said in a press release. "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."
Earlier in June, J&J shared results from the Vivacity-MG3 trial (NCT04951622). Over 24 weeks, nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the activities of daily living (MG-ADL) score.2
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."
Vivacity-MG3 was a double-blind placebo-controlled study that enrolled anti-AChR+, anti-MuSK+, and/or anti-LRP4+ gMG patients. Randomization was 1:1 with participants receiving 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 MG-ADL, a key secondary endpoint included improvement in strength and function of different muscle groups, as measured by Quantitative Myasthenia Gravis (QMG).
According to Johnson & Johnson, nipocalimab is the first and only FcRn blocker to show sustained disease control measured by improvement in MG-ADL when added to background SOC over a period of six months of consistent dosing. The duration of the Vivacity-MG3 study marked the longest period of controlled safety and efficacy assessment of an FcRn blocker in gMG.
References
1. Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis. News release. Johnson & Johnson. August 29, 2024. Accessed September 2, 2024. https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-approval-of-nipocalimab-to-treat-broadest-population-living-with-antibody-positive-generalized-myasthenia-gravis-302233966.html
2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients. News release. Johnson & Johnson. June 28, 2024. Accessed September 2, 2024. https://www.prnewswire.com/news-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class-for-broadest-population-of-myasthenia-gravis-patients-302185879.html
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