The FDA has approved Lisraya (brepocitinib) tablets for adults with dermatomyositis, marking the first FDA-approved oral treatment for the rare autoimmune disease.
The approval was based on a phase 3 randomized, double-blind, multicenter, placebo-controlled study involving 241 adults, according to an Aug. 27 news release. Participants received Lisraya 30 milligram once daily, brepocitinib 15 milligram once daily or a placebo for 52 weeks.
Participants treated with Lisraya 30 mg had a higher average Total Improvement Score at week 52 than those who received a placebo. They also showed improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week 48.
Six percent of participants treated with Lisraya 30 mg discontinued treatment due to adverse reactions, compared with 11% of those given a placebo. Lisraya 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. The approval was granted to Priovant Therapeutics.
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