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Bulevirtide FDA Approval Status

FDA Approved: No
Generic name: bulevirtide
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis D

Bulevirtide is a novel virion entry inhibitor in development for the treatment of adults with chronic hepatitis delta virus (HDV) infection.

Development timeline for bulevirtide

Oct 27, 2022Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
Nov 19, 2021Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta
Jun 24, 2021Treatment With Hepcludex (bulevirtide) Was Shown to Achieve Significant Response in Chronic Hepatitis Delta Virus After 24 Weeks

Further information

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