First Oral Dermatomyositis Treatment Approved

The FDA has approved brepocitinib (Lisraya, Priovant Therapeutics) tablets for the treatment of dermatomyositis in adults. According to the agency, Lisraya is the first FDA-approved oral treatment option for the disease.

Dermatomyositis is a rare autoimmune disease in which the immune system attacks muscle and skin, leading to chronic inflammation, progressive muscle weakness, and characteristic skin rashes. Brepocitinib is a once-daily oral Janus kinase (JAK/TYK2) inhibitor. The FDA said inhibition of JAK pathways helps reduce the inflammation that damages muscle and skin.

The efficacy and safety of brepocitinib were evaluated in a phase 3 randomized, double-blind, multicenter, placebo-controlled study (VALOR) involving 241 adults. Participants were assigned to brepocitinib 30mg once daily, brepocitinib 15mg once daily, or placebo for 52 weeks. The study measured Total Improvement Score (TIS) at week 52, a standardized tool assessing changes across 6 areas: muscle strength, physical function, skin and other disease activity, muscle enzymes, and physician and patient assessments of overall health.

At week 52, participants receiving brepocitinib 30mg had a higher average TIS than those receiving placebo. The 30mg group also showed improvements in physical function and skin disease activity and was more likely to reduce corticosteroid use by week 48. The FDA release did not provide numerical TIS values or a between-group estimate.

Some of the most common adverse reactions were upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. Adverse reactions led to discontinuation in 6% of participants receiving brepocitinib 30mg and 11% receiving placebo. Brepocitinib carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis. The FDA granted Lisraya Orphan Drug and Priority Review designations and granted the approval to Priovant Therapeutics Inc.

Source: US Food and Drug Administration. FDA approves first oral drug indicated to treat dermatomyositis in adults. News release. US Food and Drug Administration; August 27, 2026. Accessed August 28, 2026.