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News
A long-awaited win for dermatomyositis patients: the FDA has approved brepocitinib (Lisraya) as the first oral drug specifically indicated for this rare autoimmune disease. Backed by phase 3 VALOR trial data, the drug showed significant improvements in both muscle and skin outcomes compared to placebo. It's a major milestone for a condition that has long relied on therapies borrowed from other diseases.
A long-awaited win for dermatomyositis patients
The FDA has approved brepocitinib (Lisraya, Priovant Therapeutics) as the first oral drug specifically indicated for dermatomyositis in adults — a rare autoimmune disease that causes chronic skin inflammation, progressive muscle weakness, and rashes. Until now, patients largely relied on treatments designed for other conditions. Brepocitinib is a first-in-class oral TYK2/JAK1 inhibitor that targets key cytokine pathways driving the disease.
The approval was based on results from the phase 3 VALOR trial, which enrolled 241 adults with dermatomyositis. The 30 mg dose met all 10 ranked study endpoints, demonstrating meaningful improvements in muscle strength, skin disease, and quality of life — even as patients in the treatment group reduced their steroid use more than those on placebo.
By the Numbers
Why it matters: Dermatomyositis affects multiple organ systems and carries serious risks, yet had no approved oral therapy — until now. This approval gives clinicians a targeted, evidence-backed option for a patient population with significant unmet need.
