First Treatment for Chronic Hepatitis Delta Virus Receives Accelerated FDA Approval

The U.S. Food and Drug Administration has granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults suffering from chronic hepatitis delta virus (HDV) infection. This marks a significant milestone as it is the first FDA-approved treatment for this severe form of viral hepatitis, which can lead to rapid progression of liver disease. The approval was based on positive outcomes observed in the phase 3 MYR301 trial.