Posted by Michael Wonder on 28 Oct 2022
Gilead receives complete response letter from US FDA for bulevirtide for the treatment of adults with hepatitis delta virus
27 October 2022 - The US FDA has issued a complete response letter for the biologics license application for bulevirtide, an investigational entry-inhibitor for the treatment of adults with hepatitis delta virus infection and compensated liver disease.
The letter from the FDA cited concerns regarding the manufacture and delivery of bulevirtide.
