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.