FDA approves Lisraya, first oral treatment for adult dermatomyositis

The FDA has approved Lisraya (brepocitinib), marking the first oral therapy specifically indicated for adults with dermatomyositis, a rare autoimmune disease characterized by progressive muscle weakness and disabling skin disease. Lisraya is a once-daily selective TYK2/JAK1 inhibitor. The approval is based on a 52-week Phase 3 trial that demonstrated significant improvement in the Total Improvement Score compared to placebo. The drug carries a boxed warning for serious infections, mortality, malignancies, major cardiovascular events, and thrombosis.