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Nipocalimab Data Submitted for FDA Approval in Generalized Myasthenia Gravis

The application includes data from the Vivacity-MG3 study, demonstrating that individuals who received the drug had superior outcomes compared with the standard of care alone.

Johnson and Johnson have submitted a biologics license application for approval of nipocalimab as treatment of generalized myasthenia gravis (gMG). The application includes data from the Vivacity-MG3 study, demonstrating that individuals who received the drug and the standard of care (SOC) had outcomes that were superior to individuals who received the placebo plus SOC.1

FDA Myasthenia Gravis | Image Credit: ra2 studio - stock.adobe.com

Image Credit: ra2 studio - stock.adobe.com

“We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalized myasthenia gravis, a chronic, lifelong disease,” Bill Martin, PhD, global therapeutic area head of neuroscience at Johnson & Johnson Innovative Medicine, said in a news 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.”1

The study was a multicenter, randomized, double-blind, phase 3 trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of nipocalimab when used to treat gMG. Nipocalimab is a monoclonal antibody that targets neonatal Fc receptors and lowers immunoglobulin G antibodies of autoimmune disease. The study involved a screening phase (up to 4 weeks), a treatment phase (24 weeks), an extension phase (up to 2 years), and a follow-up safety visit (up to 8 weeks post-last infusion.2,3

About The Trial

Trial Name: A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

ClinicalTrials.gov ID: NCT04951622

Sponsor: Janssen Research & Development LLC

Completion Date (Estimated): April 2026

There were 180 individuals 18 years and older included in the study who had insufficient clinical response to ongoing SOC therapy and a Myasthenia Gravis–Activities of Daily Living (MA­–ADL) score of 6 or greater at screening and baseline as well as a Myasthenia Gravis Foundation of America class of IIa/b to IVa/b at screening. Investigators excluded individuals who had confirmed or suspected immunodeficiency syndrome unrelated to gMG, a thymectomy within 12 months prior to screening, or an expected myocardial infarction, unstable ischemic heart disease, or stroke, withing 12 weeks of screening.2,3

Individuals received treatment at a 1:1 ratio of either the study drug or the placebo every 2 weeks with an open-label extension. The primary end point included the average change in MA­–ADL score from baseline to weeks 22, 23, and 24. Safety and tolerability were included as secondary endpoints.1,2

In a previous study of gMG with 68 individuals (Vivacity-MG; NCT03772587), investigators found that nipocalimab and the placebo had similar incidences of treatment-emergent adverse events (TEAEs) at 83.3% and 78.6%, respectively and infections at 33.3% and 21.4%, respectively. Further, there were no deaths or discontinuations due to any TEAEs, including those of special interest.4

The FDA granted fast track designation to the drug for gMG in December 2021 and orphan drug designation in February 2021, according to the news release.1

REFERENCES
1. Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis. News release. Johnson and Johnson. August 29, 2024. Accessed August 29, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-approval-of-nipocalimab-to-treat-broadest-population-living-with-antibody-positive-generalized-myasthenia-gravis
2. Ramchandren S, Sanga P, Burcklen M, Sun H. Vivacity MG Phase 3 Study: Clinical Trial of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis. 2022. doi:https://doi.org/10.1212/01.wnl.0000903328.46907.49
3. A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis. ClincialTrials.gov identification: NCT04951622. Updated August 14, 2024. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT04951622
4. Antozzi C, Guptill J, Bril V, et al. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study. Neurology. 2024;102(2):e207937. doi:10.1212/WNL.0000000000207937
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