Product/Regulation
FDA approves Lisraya, the first oral drug indicated for adult dermatomyositis
The U.S. Food and Drug Administration on August 27, 2026, approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. The FDA page calls it the first FDA-approved oral treatment option for the disease. Roivant Sciences Ltd. furnished an 8-K the same day saying the NDA was submitted by its subsidiary Priovant Therapeutics, Inc., and that LISRAYA is available immediately in the United States. The FDA page reports a higher average Total Improvement Score at week 52 on 30 mg versus placebo. It does not print that average as a number.