Lisraya Beats Placebo in Two Phase 3 Uveitis Trials — SkimNews
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- Lisraya was more effective than placebo in treating non-infectious uveitis, Roivant and Priovant said Wednesday.
- Two Phase 3 trials of Lisraya spanned 371 patients.
- Roivant estimates 70,000 to 190,000 U.S. patients have the condition, with more than 40,000 already receiving Humira or similar therapy.
- Roivant plans to file Lisraya for approval in the first half of next year; approval would expand the drug beyond its dermatomyositis indication, granted in August.
Why it matters: Roivant has a defined regulatory step: file Lisraya in the first half of next year after a 371-patient Phase 3 program beat placebo. Approval would broaden the drug beyond dermatomyositis, giving Roivant a second indication built on the same product.
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