Roivant and its spinout Priovant said Wednesday that their immune-modifying pill Lisraya was more effective than placebo in treating the inflammatory eye disease non-infectious uveitis.
The results, from two Phase 3 trials spanning 371 patients, could unlock a new blockbuster market for Roivant. The company estimates that there are between 70,000 to 190,000 patients with the condition in the U.S., with over 40,000 of them already receiving Humira or a similar therapy.
Roivant plans to file for approval in the first half of next year. An approval would expand the drug’s use beyond the rare skin disease dermatomyositis, which it was OK’d for in August.