J&J to Challenge Argenx With Nipocalimab for Myasthenia Gravis

Johnson & Johnson has submitted a Biologics License Application for nipocalimab, an investigational monoclonal antibody, aiming for its approval to treat generalized myasthenia gravis (gMG). This application is supported by data from the Phase III Vivacity-MG3 study, which demonstrated that combining nipocalimab with standard care resulted in superior outcomes for gMG patients compared to a placebo. The efficacy of nipocalimab was assessed using the Myasthenia Gravis–Activities of Daily Living score, a quick measure of disease symptoms affecting daily activities.

Vivacity-MG3 is notable as it successfully maintained disease control across various gMG subtypes, making it a unique study in this regard. Bill Martin, the global therapeutic area head of neuroscience at J&J Innovative Medicine, expressed optimism about these findings, emphasizing the potential of nipocalimab to offer sustained disease control for gMG patients. Martin highlighted that the application submission is a crucial step in J&J's mission to innovate treatment solutions for antibody-driven diseases.

Should it receive approval, gMG will be the first condition for which nipocalimab is indicated. Nipocalimab functions by blocking the FcRn protein, thereby reducing IgG antibody levels while preserving immune function without causing broad immunosuppression. The drug has previously been recognized by the FDA with Fast Track, Orphan Drug, and Breakthrough Therapy designations for various rare and autoimmune blood disorders.

Nipocalimab was initially discovered and developed by Momenta Pharmaceuticals, which J&J acquired in August 2020 for $6.5 billion. In June 2023, J&J reported a Phase II success for nipocalimab in treating chronic autoimmune Sjögren’s disease, where the drug significantly alleviated symptoms.

With this recent filing, J&J positions itself as a competitor to argenx, which currently leads the gMG market with its drug Vyvgart (efgartigimod alpha). Vyvgart, approved by the FDA in December 2021, is a human IgG1 antibody fragment that lowers IgG levels by binding to FcRn. In June 2023, a subcutaneous formulation of Vyvgart received regulatory approval. In 2023, Vyvgart generated $1.2 billion in revenue for argenx, a significant increase from its $400 million revenue in 2022.

Another player in the gMG field is UCB, with its anti-FcRn antibody Rystiggo (rozanolixizumab-noli), which also received FDA approval in June 2023.

Nipocalimab’s journey from its initial discovery by Momenta Pharmaceuticals to its potential approval highlights J&J’s ongoing commitment to expanding its portfolio of treatments for rare and autoimmune diseases. The positive Phase III results bolster the case for nipocalimab as a promising treatment option for gMG, providing hope for patients suffering from this debilitating condition.

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