FDA Approves First-in-Class Oral Treatment for Adults With Dermatomyositis

On August 27, 2026, Roivant announced that the U.S. Food and Drug Administration (FDA) approved Brepocitinib (Lisraya), a TYK2/JAK1 inhibitor, 30 mg, for the treatment of adults with dermatomyositis (DM). Brepocitinib is a pill taken once daily. Lisraya represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM). Brepocitinib demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted. It is a first-in-class oral small molecule for dermatomyositis.