Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved agrenx SE’s VYVGART (efgartigimod alfa) intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult patients who did not see improvements from pervious treatment with steroids or non-steroidal immunosuppressive therapies (ISTs). Generalized myasthenia gravis (gMG) is a chronic autoimmune, neuromuscular skeletal disease that is characterized by muscle weakness that worsens following periods of activity and improves following periods of rest. VYVGART (efgartigimod alfa) is human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn) and prevents the recycling of IgG, one of the key proteins linked to the degradation of the neuromuscular junction in the skeletal muscles. Some of the current treatment options for generalized myasthenia gravis (gMG) include: thymectomies, monoclonal antibodies, anticholinesterase medications, immunosuppressive drugs, or plasmapheresis and intravenous immunoglobulins treatments. VYVGART (efgartigimod alfa) was approved by the U.S. Food and Drug Administration (FDA) in December of 2021 and is the first and only neonatal FcRn receptor blocker to be approved in Japan. agrenx SE is a clinical-stage biotechnology company that develops antibody-based therapies to treat severe cancers and autoimmune diseases.

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