Gilead's Hepcludex (bulevirtide‑gmod) has received FDA approval in the United States as the first‑ever treatment for chronic hepatitis delta virus (HDV) infection, despite a prior rejection linked to manufacturing concerns.
The agency granted accelerated approval in May 2026, allowing use in adults either without cirrhosis or with compensated cirrhosis, making Hepcludex the first HDV‑specific therapy available in the U.S.
The decision follows earlier setbacks:
the FDA issued a complete response letter citing manufacturing and delivery issues, but did not raise safety or efficacy concerns or require new clinical trials.
Approval is based on the Phase 3 MYR301 trial, which showed reductions in HDV RNA and normalization of liver enzyme ALT; confirmatory data on clinical outcomes are still needed for continued approval.
Widely used in Europe since 2020, Hepcludex is now positioned to become the standard‑of‑care HDV therapy in the United States, subject to ongoing regulatory and payer reviews.
Sources:
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