Gilead's Hopes for HDV Approval Delayed after CRL

Gilead's hopes for an approval in hepatitis delta virus (HDV) infection and compensated liver disease will have to wait following an FDA rejection.

The regulator issued a Complete Response Letter regarding Gilead's Biologics License Application for bulevirtide, an investigational entry-inhibitor treatment for HDV infection the company gained in its December 2020 acquisition of Germany's Myr GmbH.