Roivant’s Lisraya Beats Placebo in Two Phase 3 Trials — SkimNews
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- Roivant and its spinout Priovant said Lisraya was more effective than placebo in treating non-infectious uveitis, based on two Phase 3 trials spanning 371 patients.
- Roivant estimates that 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.
- Lisraya was approved in August for dermatomyositis; approval in uveitis would expand its use beyond the rare skin disease.
Why it matters: For Roivant, an approval in uveitis would broaden Lisraya’s existing dermatomyositis label into a market the company estimates includes 70,000 to 190,000 U.S. patients. More than 40,000 are already on Humira or similar therapy, giving the expanded indication an established treated base.
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