FDA Accelerates Approval of Gilead’s 8.5mg Hepcludex, First U.S. HDV Therapy
FDA granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5mg to treat chronic hepatitis delta virus, marking the first U.S.-approved HDV therapy, based on Phase 3 MYR301 data showing a statistically significant combined virologic and biochemical response at Week 48. Continued approval hinges on confirmatory trials verifying clinical benefits.
1. Approval Milestone
The U.S. FDA has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5mg for chronic hepatitis delta virus (HDV) in adults, establishing it as the first and only HDV therapy approved in the United States.
2. Clinical Trial Evidence
Approval was based on pivotal Phase 3 MYR301 data, which demonstrated a statistically significant combined reduction in HDV RNA and normalization of alanine aminotransferase (ALT) at Week 48 compared with delayed treatment controls.
3. Patient Population
Chronic HDV, a co-infection impacting an estimated 40,000–80,000 U.S. individuals with chronic hepatitis B, carries rapid disease progression and elevated liver failure risk, representing a significant unmet medical need.
4. Regulatory Next Steps
Continued approval for Hepcludex depends on confirmatory trials to verify clinical benefit, with ongoing monitoring of HDV RNA and ALT levels and evaluation of long-term patient outcomes.