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Medical Daily
Medical Daily
Joseph James

Mirum Plans 2027 Hepatitis D Filing After Phase 3 Win as U.S. Patients Rely on One Approved Drug

An experimental antibody for chronic hepatitis D met its main goal in a Phase 3 trial, and its developer plans to seek FDA approval in the first half of 2027, Mirum Pharmaceuticals announced on Sept. 28. The drug, brelovitug, is given as an injection under the skin once a week or once every four weeks.

That timeline matters to an estimated 80,000 Americans living with hepatitis D, the most severe form of viral hepatitis. Until this spring, they had no approved treatment at all. They now have one, a daily injection with limits on who can use it, and no second option is guaranteed.

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