CHMP Positive for Vyvgart for treatment of anti-acetylcholine receptor (AChR) antibody positive generalised myasthenia gravis.-Agenx.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vyvgart,(efgartigimod) intended for the treatment of anti?acetylcholine receptor (AChR) antibody positive generalised Myasthenia Gravis. The applicant for this medicinal product is Argenx.
Vyvgart will be available as 20mg/ml concentrate for solution for infusion. The active substance of Vyvgart is efgartigimod alfa, an immunosuppressant (ATC code: L04AA58). Efgartigimod alfa is a fragment of human IgG1 antibody that binds to the neonatal Fc Receptor (FcRn), thereby decreasing the levels of circulating IgG, including pathogenic IgG autoantibodies.
Benefits of Vyvgart include a decrease in functional disability as rated by patients, and less disease severity as assessed by qualified physicians, as compared with placebo in clinical trials. The most common side effects are upper respiratory tract infections and urinary tract infections.
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