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STAT+: Roivant says closely watched immune drug succeeded in new eye disease

By · Via STAT Health · Published by Everything Blog

In short

Roivant's immune-modifying drug Lisraya demonstrated effectiveness in managing non-infectious uveitis, an inflammatory eye disease, in two Phase 3 trials involving 371 patients. The drug is expected to be approved in the first half of next year, potentially expanding its market beyond dermatomyositis, where it was previously approved. This development could unlock a significant new market for Roivant, which is estimated to have over 40,000 patients already receiving similar therapies.

Key points

  • Roivant's immune-modifying drug Lisraya showed promising results in treating non-infectio…: Roivant's immune-modifying drug Lisraya showed promising results in treating non-infectious uveitis, an inflammatory eye disease, in two Phase 3 trials involving 371 patients.
  • The drug is expected to be approved in the first half of next year, potentially expanding…: The drug is expected to be approved in the first half of next year, potentially expanding its market beyond dermatomyositis, where it was previously approved.
  • This development could unlock a significant new market for Roivant, which is estimated to…: This development could unlock a significant new market for Roivant, which is estimated to have over 40,000 patients already receiving similar therapies.

Sources checked by our analysis pipeline: 1

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.

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Original source: www.statnews.com

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