The U.S. Food and Drug Administration has granted approval for Lisraya (brepocitinib) 30 mg as a treatment for adults with dermatomyositis, a rare autoimmune disease marked by muscle weakness and skin lesions. The approval follows the Phase 3 VALOR study, a 52‑week trial described by Priovant Therapeutics as the largest ever conducted for the condition.
In the VALOR trial, 55% of patients receiving Lisraya achieved a moderate or greater improvement on the Myositis Improvement Total Score with minimal or no corticosteroid use, compared with 30% in the placebo arm. Among participants taking at least 7.5 mg of oral corticosteroids daily at baseline, 62% on Lisraya reduced steroid use to minimal or zero levels, versus 38% on placebo. Overall, 45% of Lisraya‑treated patients discontinued corticosteroids completely, against 29% of those on placebo.
Lisraya is a first‑in‑class TYK2/JAK1 inhibitor administered as a daily oral tablet and is available in the United States through a limited specialty pharmacy network. The company also launched the Lisraya My Compass support program, allowing eligible patients to obtain the medication at no cost, starting at US$0 per month.
The most frequently reported adverse reactions in the trial included upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, falls, influenza and acne. The product carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Prior to approval, the FDA granted Lisraya both Priority Review and Orphan Drug designations.
Priovant Therapeutics, a subsidiary of Roivant Sciences, announced the approval from its Durham, North Carolina headquarters.
