MYR Pharmaceuticals today announced that the 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).
| BAD HOMBURG, Germany, May 29, 2020 /PRNewswire/ -- MYR Pharmaceuticals today announced that the 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) About MYR Pharmaceuticals Contact Details SOURCE MYR Pharmaceuticals |
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