FDA approves Gilead’s Hepcludex injection to treat chronic HDV infection

The U.S. Food and Drug Administration approved Hepcludex injection to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis, liver cancer, liver failure, and even death. “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, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.” The FDA granted the approval to Gilead (GILD) Sciences, Inc.