Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization (CMA) for the medicinal product HEPCLUDEX® (bulevirtide, formally known as Myrcludex B). HEPCLUDEX® is intended for the treatment of chronic hepatitis delta virus (HDV) infection in HDV-RNA positive adult patients with compensated liver disease. HEPCLUDEX® is a first-in-class entry inhibitor that binds and inactivates the essential hepatitis B (HBV) and HDV receptor on hepatocytes.
The benefit of HEPCLUDEX® is shown by an effective reduction of HDV RNA levels and improvement of liver inflammation.
"There is a high unmet medical need for patients suffering from chronic HDV infection," said Alexander Alexandrov, Chief Medical Officer of MYR GmbH. "We are encouraged by today´s positive CHMP opinion reinforcing the potential to become the first approved therapy for this most severe form of viral hepatitis."
The European Commission (EC) will review the CHMP recommendation and a final decision on the Conditional Marketing Authorization for HEPCLUDEX® in the EU is expected in the coming months. Upon positive EC decision, bulevirtide will be available under the trade name HEPCLUDEX® in the EU.
About HEPCLUDEX® (bulevirtide)
HEPCLUDEX® is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor (NTCP receptor) on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. HEPCLUDEX® has received Orphan Designation for treatment of HDV infection from EMA and FDA, PRIME scheme eligibility from EMA, and a breakthrough therapy designation from FDA.