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Netherlands-based argenx SE has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVGART™ (efgartigimod alfa) intravenous infusion for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).
VYVGART is the first-and-only neonatal Fc receptor (FcRn) blocker approved in Japan.
Generalised myasthenia gravis is a rare and chronic neuromuscular disease characterized by debilitating and potentially life-threatening muscle weakness. VYVGART is a human IgG1 antibody fragment that binds to FcRn, resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. The action of IgG autoantibodies at the neuromuscular junction is a key driver of gMG.