Mirum's brelovitug meets primary endpoint in Phase 3 hepatitis delta trial
MIRM•Mirum Pharmaceuticals said brelovitug met the primary endpoint in its second pivotal Phase 3 trial for chronic hepatitis delta, improving viral response and liver inflammation. The company plans to file a U.S. biologics license application in the first half of 2027, with a potential launch in the fourth quarter, pending approval.
1. Trial results and plans
Brelovitug met the primary endpoint in AZURE-4, Mirum Pharmaceuticals’ second pivotal Phase 3 trial for chronic hepatitis delta, improving viral response and liver inflammation; no new safety signals emerged. Full results will be presented at an upcoming medical congress, and the company plans a U.S. biologics license application in the first half of 2027, with a potential fourth-quarter launch that year pending approval.
