Lisraya approved as first oral therapy for adult dermatomyositis
- Sponsor
- Priovant Therapeutics
- Drug
- Lisraya · brepocitinib
- Indication
- dermatomyositis in adults
FDA approved Priovant's Lisraya (brepocitinib) 30 mg once daily for adults with dermatomyositis, the first FDA-approved oral treatment and the first targeted therapy for the condition. Based on the Phase 3 VALOR trial.
What this means
Dermatomyositis is a rare autoimmune disease that inflames the skin and muscles, causing progressive weakness and a distinctive rash. Until now doctors have relied on steroids and off-label immune-suppressing drugs, none of them specifically approved for the condition. Lisraya (brepocitinib) is a once-daily pill that blocks two signaling enzymes, TYK2 and JAK1, which help drive the immune-system misfiring behind the disease. In the Phase 3 VALOR trial patients on Lisraya had higher one-year Total Improvement Scores (a composite of muscle strength, physical function, skin activity, muscle-enzyme levels, and physician and patient assessments) than those on placebo. This is both the first FDA-approved oral therapy and the first targeted therapy for adult dermatomyositis; approval landed six days ahead of the September 3 PDUFA.