Roivant Sciences and its subsidiary Priovant Therapeutics announced positive results from the Phase 3 CLARITY program for its drug, brepocitinib, in treating non-infectious uveitis (NIU). The drug achieved statistically significant benefits on the primary and all key secondary endpoints in two identical trials, demonstrating its potential as a new non-steroid treatment option.
Key Details
- Primary Endpoint: The median time to treatment failure for patients on brepocitinib was greater than 48 weeks, compared to approximately 12 weeks for patients on placebo (p<0.0001).
- Steroid-Sparing Benefit: At Week 48, 62% of patients on brepocitinib achieved steroid-free quiescence, compared to 20% on placebo (p<0.0001).
- Regulatory Path: Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027.