MYR Pharmaceuticals’ Hepcludex Approved in Europe for Hepatitis D

The European Commission has granted a conditional marketing authorization to MYR Pharmaceuticals’ Hepcludex (bulevirtide) for the treatment of adults with chronic hepatitis delta virus (HDV) infection and non-symptomatic liver disease.

The approval was based on two phase 2 trials which demonstrated the drug’s tolerability and safety as well as a significant improvement in liver function.

Hepcludex has received Orphan Drug designations from the FDA and the European Medicines Agency for the treatment of HDV infection.