Roivant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.
Roivant announced FDA approval of LISRAYA (brepocitinib) for adults with dermatomyositis, making it the first targeted therapy approved for this rare autoimmune disease. The approval was based on the Phase 3 VALOR trial, where 55% of patients on LISRAYA achieved moderate or better improvement with minimal steroid use, compared to 30% on placebo. LISRAYA is available immediately in the U.S.
Key figures
- Drug Name
- LISRAYA (brepocitinib)
- Phase Of Trial
- Phase 3
- Dosage
- 30 mg
- Efficacy responders
- 55% vs 30%
- Steroid discontinuation
- 45% vs 29%
- Steroid tapering success
- 62% vs 38%
- Patient reported improvement
- >4x vs placebo
AI analysis
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