Roivant says FDA approves LISRAYA for adults with dermatomyositis

Roivant says the FDA has approved LISRAYA (brepocitinib) 30 mg to treat adults with dermatomyositis in the U.S.

Launch starts immediately; the product is positioned as a once-daily oral TYK2/JAK1 inhibitor and the first targeted therapy cleared for the disease.

Approval was based on the Phase 3 VALOR trial; 55% reached moderate-or-better improvement with minimal or no steroid use at week 52.