Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication

Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness.

In the two pivotal trials, Clarity‑1 and Clarity‑2, patients treated with brepocitinib remained free from treatment failure for a median of more than 48 weeks, compared with just 12 weeks for those receiving placebo. The drug also allowed patients to go 40 weeks without needing immunosuppressive steroids and met every secondary endpoint, including resolution of macular edema.

Priovant already holds FDA approval for brepocitinib (brand name Lisraya) to treat adult dermatomyositis. The company plans to submit a supplemental application in the first half of next year to seek approval for the new uveitis indication.