Nipocalimab Data Submitted for FDA Approval in Generalized Myasthenia Gravis

Author(s):

Ashley Gallagher, Associate Editor

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

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“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