The FDA has approved Johnson & Johnson’s drug Imaavy for the treatment of generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder.
The approval covers adults and pediatric patients 12 and older who test positive for anti-acetylcholine receptor or anti-muscle-specific kinase antibodies, according to an April 30 news release from the company.
Imaavy is a part of a class of drugs called FcRn blockers, which work by reducing levels of immunoglobin G antibodies that drive disease activity in gMG.
The approval is based on results from an ongoing VivaCity MG3 study, which showed that the drug combined with standard of care improved disease control over 24 weeks significantly compared to a placebo.
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