FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults Lisraya is the first FDA-approved oral treatment option for patients with dermatomyositis, addressing the high unmet need for this rare disease.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults?utm_medium=email&utm_source=govdelivery FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults The U.S. Food and Drug Administration has approved Lisraya (brepocitinib), for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya offers patients an important new alternative, providing an efficacious oral treatment with an acceptable risk profile. Lisraya is a once-daily pill that works by blocking certain proteins in the body, called Janus kinases, that become overactive in people with dermatomyositis. In a 52-week phase 3 clinical trial, patients treated with Lisraya achieved statistically significant and clinically meaningful improvements in disease activity compared to placebo and were more likely to reduce their corticosteroid use. Lisraya carries a boxed warning for serious infections, increased all-cause mortality, malignancy, major adverse cardiovascular events, and thrombosis. The approval was granted to Priovant Therapeutics, Inc.