On May 8, 2026, argenx announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of VYVGART (efgartigimod alfa) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase) for the treatment of all adult patients living with generalized myasthenia gravis (gMG). This expansion covers all serotypes, including those with acetylcholine receptor (AChR) antibodies and muscle-specific tyrosine kinase (MuSK) antibodies, among others.
VYVGART and VYVGART Hytrulo are now the first and only approved treatments for all serotypes of adult gMG patients. The approval is based on data from clinical trials, including the ADAPT and ADAPT+ studies, which demonstrated efficacy and safety across different antibody profiles. The FDA's decision marks a significant expansion from the previous approval, which was limited to AChR antibody-positive patients.
Dr. Jan van de Winkel, CEO of argenx, stated, 'This expanded approval underscores our commitment to addressing the unmet needs of all gMG patients, regardless of their serotype.' The company plans to make the treatments available to eligible patients immediately.
Generalized myasthenia gravis is a chronic autoimmune disease that causes muscle weakness and fatigue. The expanded approval is expected to benefit a broader patient population, including those with rare serotypes who previously had limited treatment options.
