Roivant Announces FDA Approval for LISRAYA™, a New Dermatomyositis Treatment

Roivant Sciences announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA™ (brepocitinib) for the treatment of adults with dermatomyositis (DM). Developed by its subsidiary Priovant Therapeutics, LISRAYA™ is the first targeted therapy approved for this debilitating autoimmune disease and is available for prescription in the U.S. immediately.

Key Details

• Drug Profile: LISRAYA™ (brepocitinib) is a first-in-class, once-daily oral TYK2/JAK1 inhibitor.
• Approval & Availability: FDA approval was granted on August 27, 2026, making the drug immediately available for commercial launch in the United States.
• Clinical Basis: The approval is supported by positive results from the landmark Phase 3 VALOR trial, the largest study ever conducted in dermatomyositis, which demonstrated robust efficacy and steroid-sparing benefits.