Gilead Sciences Gets FDA Green Light for Chronic HDV Drug

By Elias Schisgall

Gilead Sciences received accelerated approval for a chronic hepatitis delta virus treatment from the Food and Drug Administration.

The FDA said the Hepcludex treatment, known also as bulevirtide-gmod, is the first approved treatment for chronic HDV infection in the U.S.

The agency approved an 8.5mg dose for adults with chronic HDV. Its approval was based on reductions in HDV RNA and the normalization of alanine aminotransferase based on results from a Phase 3 study.

"This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need," Chief Medical Officer Dietmar Berger said.

Between 2% and 4% of people in the U.S. with chronic hepatitis B virus are also affected by HBV, representing between 40,000 and 80,000 people, Gilead said.

Bulevirtide is available in 2mg doses for patients with HDV in Europe and certain other countries.

"Today's approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available," said Wendy Carter, acting director of the Office of Infectious Diseases in FDA's Center for Drug Evaluation and Research.

Shares for Gilead rose 2.8%, to $134.18.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

May 22, 2026 14:41 ET (18:41 GMT)