Nipocalimab

Johnson & Johnson received FDA priority review for nipocalimab, targeting generalized myasthenia gravis in antibody-positive patients. This designation could expedite treatment for the chronic autoimmune disorder, currently without a cure. Nipocalimab, part of J&J's $6.5B Momenta acquisition, is also being studied for other autoimmune diseases.

Myasthenia gravis (MG) is an autoimmune disease affecting neuromuscular signaling, impacting 700,000 globally. The Phase 3 Vivacity-MG3 study evaluated nipocalimab's efficacy and safety in gMG patients, showing promise. Nipocalimab, targeting FcRn to reduce IgG antibodies, has received FDA and EMA designations for various conditions, including gMG.

Johnson & Johnson's nipocalimab received FDA Priority Review for treating generalized myasthenia gravis (gMG) in antibody positive patients, supported by Phase 3 Vivacity-MG3 study results showing sustained disease control. Nipocalimab, targeting FcRn to reduce IgG antibodies, also seeks EMA approval and holds Breakthrough Therapy Designation for Sjögren's disease.

Cyrus Biotechnology's CYR212, an AI-engineered IgG protease, shows promise for treating chronic IgG-driven autoimmune diseases with extended half-life and reduced immunogenicity. Preclinical data indicate rapid, sustained IgG depletion without immunogenicity, contrasting with wild type IdeS. CYR212 targets a $20B market, offering potential improvements over current anti-FcRn biologics in dosing convenience and efficacy for diseases like gMG and ITP.

Johnson & Johnson's Nipocalimab, a monoclonal antibody targeting FcRn to reduce IgG antibodies, has been accepted for FDA priority review for treating generalized myasthenia gravis (gMG). A phase III trial showed sustained disease control. If approved by April 2025, it could offer a targeted treatment for gMG patients.

2024 saw key FDA approvals, including a new schizophrenia treatment and a first in-class immunotherapy, but fell short of 2023's 55 novel nods. 2025 may see an uptick, with potential approvals for Vertex's non-opioid suzetrigine, Novo Nordisk's semaglutide for kidney and liver conditions, J&J's nipocalimab for myasthenia gravis, and AstraZeneca/Daiichi Sankyo's Enhertu for HER2-low breast cancer.

The Myasthenia Gravis Treatment Market is set to grow significantly by 2034, driven by improved diagnostics, emerging therapies, and increased awareness. Key companies like Horizon Therapeutics and Amgen are developing novel treatments. The market size reached USD 4,950 million in 2023, with the U.S. seeing 129 thousand cases.

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