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argenx Announces VYVGART™ Approval in Japan for the Treatment of Generalized Myasthenia Gravis

Published: 2022-01-20 07:00:00 ET

VYVGARTTM (efgartigimod alfa) is the first-and-only FcRn blocker approved in Japan

Ministry of Health, Labour and Welfare (MHLW) decision marks second regulatory approval of VYVGART as part of global launch strategy, following approval in U.S. on December 17, 2021

BREDA, Netherlands--(BUSINESS WIRE)-- Regulatory News:

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today 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.

"People living with gMG around the world continue to experience severe disease burden despite treatment with commonly-used therapies. We are extremely proud to deliver the first-and-only approved FcRn blocker in Japan to a broad population of gMG patients, regardless of antibody status," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Our commercial teams are ready and motivated to be serving as many people as possible who are living with this debilitating disease and we look forward to collaborating with the Japanese government to enable patient access. With today’s approval of VYVGART in Japan, the recent U.S. FDA approval, and ongoing review of our application in Europe, we continue to advance rapidly toward achieving our goal of delivering this innovative, targeted treatment option globally.”

Generalized 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.²

The approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-acetylcholine receptor (AChR) antibody positive gMG patients were responders on the myasthenia gravis activities of daily living (MG-ADL) scale following treatment with VYVGART compared with placebo (68% vs. 30%; p

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