The U.S. Food and Drug Administration has granted approval to Lisraya (brepocitinib), an oral 30 mg once‑daily TYK2/JAK1 inhibitor developed by Priovant Therapeutics, for the treatment of adults with dermatomyositis, a rare autoimmune disease that causes muscle weakness and skin lesions.
Approval follows the Phase 3 VALOR trial, a 52‑week study described by the company as the largest of its kind. In the trial, 55% of patients receiving Lisraya achieved a moderate or better improvement on the myositis Total Improvement Score while reducing or eliminating steroid use, versus 30% on placebo. Among participants who began the study on at least 7.5 mg per day of corticosteroids, 62% on Lisraya tapered to minimal or no steroid use compared with 38% on placebo, and 45% discontinued steroids entirely versus 29% on placebo.
Lisraya will be distributed immediately in the United States through a limited network of specialty pharmacies. Eligible patients can access the drug at no cost under the Lisraya My Compass Support program, which may reduce out‑of‑pocket expenses to $0 per month.
The FDA previously assigned Lisraya priority review and orphan‑drug designation. The label carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. The most frequently reported adverse reactions in the VALOR trial included upper respiratory infections, headache, fatigue, urinary‑tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, falls, influenza and acne.
Priovant Therapeutics, listed on NASDAQ under ROIV, is based in Durham, North Carolina.
