Posted by Michael Wonder on 24 May 2026
FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus
22 May 2026 - Approval introduces the first FDA approved therapy for this disease with limited treatment options and high unmet need.
Gilead Sciences today announced that the US FDA has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus infection, making it the first and only approved treatment for hepatitis delta virus infection in the US.
