FDA approves Lisraya for dermatomyositis in adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as the first oral treatment for dermatomyositis in adults.
The U.S. Food and Drug Administration (FDA) has given approval to Lisraya, an oral medication (brepocitinib) for dermatomyositis in adults. The decision followed a phase 3 trial involving 241 adults with dermatomyositis who were randomly assigned to receive daily doses of Lisraya (30 mg or 15 mg) or a placebo. After 52 weeks, those who took Lisraya 30 mg showed a higher average Total Improvement Score, indicating better overall clinical response and disease control compared to those on placebo.
Additionally, patients treated with Lisraya experienced improvements in physical function, skin disease activity, and were more likely to decrease corticosteroid use by week 48. The most frequent side effects of Lisraya included upper respiratory tract infections, headaches, fatigue, urinary tract infections, and nausea. Discontinuation due to adverse reactions occurred in 6% of Lisraya 30 mg patients and 11% of those on placebo.
Dr. Nikolay Nikolov of the FDA Center for Drug Evaluation and Research emphasized that this approval is a significant advancement, providing patients and healthcare providers with an approved oral therapy for the rare and debilitating disease of dermatomyositis. Lisraya was granted approval by Priovant Therapeutics.
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