Roivant's Priovant Reports Phase 3 Wins for Brepocitinib in Non-Infectious Uveitis, Plans Regulatory Filing

Priovant Therapeutics, a Roivant subsidiary, will seek regulatory approval for a new indication for brepocitinib after the anti-inflammatory drug succeeded in two Phase 3 trials in non-infectious uveitis, an eye condition that can cause blindness. Roivant announced the results Wednesday. In the Clarity-1 and Clarity-2 studies, patients receiving brepocitinib went a median of more than 48 weeks before treatment failure, versus 12 weeks for placebo, and lasted 40 weeks without immunosuppressive steroids. The drug met all secondary endpoints, including resolution of macular edema. Priovant already holds FDA approval to sell brepocitinib as Lisraya for dermatomyositis, cleared in late August. It plans to submit a supplemental application in the first half of next year. Priovant was formed in 2022 with Pfizer, which holds a 25% stake. Stifel analyst Alex Thompson called the data further validation of a potential multi-indication franchise; Cantor Fitzgerald's Prakhar Agrawal estimated peak sales of $5 billion for the uveitis indication.