FDA Approves Lisraya as First Oral Therapy for Adult Dermatomyositis

The US Food and Drug Administration (FDA) approved Lisraya (brepocitinib), an oral Janus kinase (JAK)/tyrosine kinase 2 inhibitor, for adults with dermatomyositis. The approval, granted to Priovant Therapeutics Inc., establishes Lisraya as the first FDA-approved oral therapy indicated for this rare autoimmune disease affecting muscles and skin. The agency granted Orphan Drug and Priority Review designations.

Approval was supported by a phase 3 randomized, double-blind, placebo-controlled trial involving 241 adults. Participants received brepocitinib 30 mg once daily, brepocitinib 15 mg once daily, or placebo for 52 weeks. At week 52, the 30-mg group achieved a higher mean Total Improvement Score than the placebo group, with improvements in physical function and skin disease activity. Patients receiving 30 mg were also more likely to reduce corticosteroid use by week 48.

Common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. A boxed warning addresses serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis.

For dermatologists and patients, this approval provides a new alternative targeting the JAK-mediated inflammation that damages the muscles and skin in dermatomyositis to control both cutaneous and systemic manifestations.

Reference

FDA approves first oral drug indicated to treat dermatomyositis in adults. News release. US Food and Drug Administration. August 27, 2026. Accessed August 31, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults