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Home » MYR Pharmaceuticals’ Hepcludex Approved in Europe for Hepatitis D
MYR Pharmaceuticals’ Hepcludex Approved in Europe for Hepatitis D
August 5, 2020
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.
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