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Home » FDA Approves Argenx’s Vyvgart for Treatment of Myasthenia Gravis
FDA Approves Argenx’s Vyvgart for Treatment of Myasthenia Gravis
The FDA has approved Argenx’s Vyvgart (efgartigimod) for treating adult patients with generalized myasthenia gravis (gMG), a rare, autoimmune neuromuscular disease that can cause weakness in the skeletal muscles.
The approval was supported by positive phase 3 data showing 68 percent of patients responded to treatment at 26 weeks vs. only 30 percent of patients in the placebo arm. The late-stage trial enrolled an estimated 167 volunteers in North America, Europe and Japan.
The company’s first approved drug, Vyvgart, is in a new class of medications that works by reducing the amount of an antibody responsible for disease progression.
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