August 27, 2026——The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. It is the first FDA-approved oral treatment for this rare autoimmune disease, addressing a long-standing unmet need.
Dermatomyositis causes the immune system to attack muscle and skin, leading to chronic inflammation, progressive muscle weakness, and distinctive rashes. For decades, patients have relied mainly on off-label therapies and corticosteroids.
Lisraya is a once-daily oral Janus kinase (JAK/TYK2) inhibitor. By blocking JAK signaling pathways central to immune and inflammatory responses, it reduces the harmful inflammation damaging muscle and skin.
"This approval gives patients and providers an approved oral therapy proven to help manage this rare, debilitating disease," said Dr. Nikolay Nikolov, Director of the FDA's Office of Immunology and Inflammation.
Clinical Data
Efficacy and safety were evaluated in a Phase 3 randomized, double-blind, placebo-controlled study (NCT05437263) enrolling 241 adults. Participants received Lisraya 30 mg once daily, Lisraya 15 mg once daily, or placebo for 52 weeks. The primary endpoint was the Total Improvement Score (TIS) at Week 52, a composite measure spanning muscle strength, physical function, skin activity, muscle enzymes, and physician/patient global assessments.
Patients on Lisraya 30 mg achieved a significantly higher average TIS at Week 52 versus placebo, with improvements in physical function and skin disease activity and greater likelihood of reducing corticosteroid use by Week 48.
Safety
Most common adverse reactions were upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. Discontinuation due to adverse events occurred in 6% of Lisraya 30 mg patients versus 11% on placebo.
Lisraya carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis.
Regulatory Status
The FDA granted Orphan Drug and Priority Review designations. Approval was granted to Priovant Therapeutics Inc.
