Gilead’s Hepcludex Accelerated FDA Approval Marks First US HDV Treatment
GILD•Gilead Sciences won FDA accelerated approval for Hepcludex (bulevirtide-gmod) to treat chronic HDV in adults without cirrhosis or with compensated cirrhosis, making it the first US therapy for hepatitis D. Approval follows orphan designation and Phase III MYR301 results showing HDV RNA reductions and ALT normalization at Week 48.
1. FDA Approval Milestone
FDA granted accelerated approval to Hepcludex for chronic HDV in adults without cirrhosis or with compensated cirrhosis, making it the first approved treatment for hepatitis D in the US.
2. Phase III MYR301 Trial Results
The pivotal trial enrolled 150 adults aged 18–65 with chronic HDV, demonstrating significant reductions in HDV RNA and normalization of ALT at Week 48 versus control, meeting primary endpoints.
3. Unmet Medical Need and Market Potential
Chronic HDV co-infection carries up to 50% five-year mortality and affects patients lacking viable therapies in the US, creating a new market segment for Gilead in viral hepatitis.
4. Competitive and Global Context
Hepcludex was conditionally approved in Europe in 2020 and is available in Australia, Canada and Israel, while key competitors like Vir Biotechnology and Mirum Pharmaceuticals are advancing HDV candidates in late-stage trials.
