FDA Approves Lisraya for Dermatomyositis in Adults

TUESDAY, Sept. 1, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as the first oral treatment of dermatomyositis in adults.

The approval was based on results from a phase 3 trial in which 241 adults with dermatomyositis were randomly assigned to receive Lisraya (30 mg once daily or 15 mg once daily) or placebo. At week 52, those treated with Lisraya 30 mg had a higher average Total Improvement Score (indicating greater clinical response and disease control) versus placebo. Additionally, those treated with Lisraya had improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week 48.

The most common adverse reactions to Lisraya included upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. Discontinuation due to adverse reactions occurred in 6 percent of participants treated with Lisraya 30 mg and 11 percent of those receiving placebo.

“Today”s approval is a meaningful step forward, giving patients and their health care providers an approved oral therapy proven to help manage this rare and debilitating disease,” Nikolay Nikolov, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement.

Approval of Lisraya was granted to Priovant Therapeutics.

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