Treats chronic hepatitis delta virus (HDV) infection. BLA 761468, held by Gilead Sciences Inc. Bulevirtide-Gmod.
As of Nov 13, 2026, BLA 761468 (Hepcludex), held by Gilead Sciences Inc, was first approved by FDA on May 22, 2026, with 0 approved supplements and 0 published complete response letters.
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hepcludex8.5MG · injection;powder,for solution | Bulevirtide-Gmod | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
