Posted by Michael Wonder on 05 May 2023
CHMP adopts positive opinion recommending Hepcludex (bulevirtide) for full marketing authorization for the treatment of hepatitis delta virus
4 May 2023 - If granted by the European Commission, Hepcludex will become the only approved treatment for HDV in the EU.
Gilead Sciences today announced that the CHMP of the EMA has adopted a positive opinion for Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta virus and compensated liver disease, and recommended granting full marketing authorisation that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with hepatitis delta virus urgent access to treatment.
