The U.S. Food and Drug Administration (FDA) approved LISRAYA (brepocitinib) for adults with dermatomyositis. Roivant Sciences' subsidiary, Priovant Therapeutics, developed the once-daily oral pill. The medication is available for immediate prescription in the U.S.
LISRAYA represents the first and only targeted therapy approved for this condition. Dermatomyositis is a rare systemic autoimmune disease defined by progressive muscle weakness and painful skin rashes. This approval ends decades of limited treatment options for patients.
The FDA decision followed positive results from the Phase 3 VALOR study. This trial stands as the largest clinical study ever conducted for dermatomyositis. LISRAYA functions as a first-in-class inhibitor targeting immune pathways involved in the disease's pathogenesis.