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FDA Approves Lisraya as First Oral Treatment for Adult Dermatomyositis

Regulators cited phase 3 VALOR data showing sustained muscle and skin benefit, with the drug’s label carrying a boxed warning for serious infections, cardiovascular events, cancer, and thrombosis.

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS/Jason Reed (UNITED STATES HEALTH)
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Overview

  • Brepocitinib, sold as Lisraya, won FDA approval Thursday, Aug. 27 and Priovant said the once-daily pill is available immediately in the United States.
  • The approval rested on the phase 3 VALOR trial and prespecified skin analyses that showed greater overall improvement versus placebo at 52 weeks and rapid, durable cutaneous benefit.
  • In VALOR the 30 mg dose produced a mean Total Improvement Score of 46.5 at week 52 versus 31.2 for placebo, and it outperformed placebo across key secondary endpoints.
  • Lisraya is a selective TYK2–JAK1 inhibitor that reduced steroid use in trial analyses but carries a boxed warning for serious infections, increased all-cause mortality, major adverse cardiovascular events, malignancy, and thrombosis and was associated with common side effects such as upper respiratory infection, headache, fatigue, nausea, and urinary tract infection.
  • The approval creates an oral alternative to high‑dose steroids, IVIG, and other therapies for an estimated 40,000–70,000 U.S. patients with dermatomyositis and will shift clinical decisions toward weighing clear clinical benefit against class safety risks and close patient monitoring.