CHMP recommends approval of Hepcludex for chronic hepatitis delta virus.- Myr

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Hepcludex (bulevirtide), from MYR GmbH, intended for the treatment of chronic hepatitis delta virus (HDV) infection in adult patients with compensated liver disease. Hepcludex will be available as a 2 mg powder for solution for injection. Bulevirtide blocks the entry of hepatitis B virus (HBV) and HDV into hepatocytes by binding to and inactivating NTCP, a bile salt liver transporter that serves as an essential HBV/HDV entry receptor. The benefit with Hepcludex is its ability to effectively reduce HDV RNA levels and signs of liver inflammation in treated patients. The most common side effects are increases in bile salts, injection site reactions and exacerbation of hepatitis after discontinuation of bulevirtide. Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.