FDA Rejects Bulevirtide for Hepatitis D

[melanie]

The US Food and Drug Administration (FDA) has declined to approve bulevirtide, Gilead Sciences' drug for the treatment of hepatitis delta virus (HDV) infection and compensated liver disease. In a complete response letter, the FDA voiced concerns over the production and delivery of bulevirtide, an investigational, first-in-class HDV entry-inhibitor that received conditional approved in Europe in 2020. The FDA did not request new studies to evaluate the safety and efficacy of bulevirtide.

[Lehina]

@melanie Chronic HDV infection is the most severe form of viral hepatitis. It is associated with a poor prognosis and high mortality rates. There are currently no approved treatments for HDV in the United States. Bulevirtide was granted breakthrough therapy and orphan drug designations by the FDA. Parsey said the company looks forward to continuing our active discussions with FDA so that we may bring bulevirtide to people living with HDV in the US as soon as possible