FDA approves Lisraya tablets for adults with dermatomyositis

The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for adults with dermatomyositis, a rare autoimmune disease that affects muscles and skin.

The approval gives patients a once-daily oral treatment for a condition that can cause chronic inflammation, progressive muscle weakness and distinctive skin rashes, according to the FDA.

The agency said the decision was based on a phase 3 randomized, double-blind, multicenter, placebo-controlled study that enrolled 241 adults with dermatomyositis. Participants received Lisraya 30 mg once daily, brepocitinib 15 mg once daily or placebo for 52 weeks.

The FDA said the study used Total Improvement Score, or TIS, at week 52 as its main measure. TIS tracks changes across six areas, including muscle strength, physical function, skin and other disease activity, muscle enzymes, and physician and patient assessments of overall health.

Patients who received Lisraya 30 mg had a higher average TIS score at week 52 than placebo recipients, the FDA said. The agency also said the treatment was linked to improvements in physical function and skin disease activity, and that participants were more likely to reduce corticosteroid use by week 48.

The FDA said Lisraya is a Janus kinase, or JAK/TYK2, inhibitor taken as a once-daily tablet. The agency granted the drug Orphan Drug and Priority Review designations before approval, according to the release.

The FDA said common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection and nausea. Discontinuation because of adverse reactions was reported in 6% of participants in the Lisraya 30 mg group and 11% of placebo recipients.

Lisraya carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events and thrombosis, the FDA said.

Nikolay Nikolov, M.D., an FDA official, said the approval gives patients an approved oral therapy for this rare and debilitating disease.

The FDA said the approval was granted to Priovant Therapeutics Inc. The release did not say when the drug will be available to patients.

Sources

• FDA press release: FDA approves first oral drug indicated to treat dermatomyositis in adults

Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.