The U.S. FDA has issued a complete response letter for Gilead's bulevirtide, rejecting the company's push to bring the first drug therapy for hepatitis delta virus (HDV) to the U.S. market.
In the CRL, the FDA cited concerns regarding the manufacture and delivery of bulevirtide. No new studies to evaluate the safety and efficacy of the drug have been requested, says Gilead.
Bulevirtide is an investigational entry-inhibitor for the treatment of adults with HDV infection and compensated liver disease. Hep D occurs only in the presence of the hepatitis B virus — and there are no treatments available on the U.S. market.
Gilead picked up bulevirtide through its Dec. 2020 acquisition of MYR GmbH. At the time, the drug had conditional approval from the EMA and had already been launched in France, Germany and Austria. Gilead has been working to implement process improvements to the manufacturing of bulevirtide since the buyout.
Disappointed with the CRL, the drugmaker says it will continue to discuss manufacturing and product delivery improvements with the FDA.
