Argenx SE (ARGX) has announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted approval for the intravenous (IV) usage of Vyvgart (efgartigimod alfa) in adults suffering from primary immune thrombocytopenia (ITP).
The endorsement of Vyvgart was principally grounded on the outcomes produced by the global Phase 3 ADVANCE-IV trial. This trial achieved its primary goal by conclusively showing that a significantly larger percentage of chronic ITP patients, who were administered Vyvgart, experienced a consistent response in their platelet count when contrasted with a placebo.
Moreover, the most commonly documented side effects associated with Vyvgart were found to be respiratory tract infection, headache, and urinary tract infection.
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