EMA recommends marketing authorisations for Epclusa and Zepatier to treat hepatitis C virus

30 May 2016 (Last Updated May 30th, 2016 18:30)

The European Medicines Agency (EMA) has recommended the approval of marketing authorisations for two latest combination therapies against chronic (long-term) hepatitis C virus (HCV) infection in the European Union (EU).

viruis

The European Medicines Agency (EMA) has recommended the approval of marketing authorisations for two latest combination therapies against chronic (long-term) hepatitis C virus (HCV) infection in the European Union (EU).

The two new medicines that can treat HCV infection include Zepatier (grazoprevir / elbasvir) and Epclusa (sofosbuvir / velpatasvir).

HCV infection affects between 0.4% and 3.5% of people in different EU Member States, and is a major reason for liver transplantation in the region.

The Zepatier and Epclusa medicines help block the action of proteins required for the replication of the virus.

Epclusa helps in blocking the NS5B and NS5A proteins, while Zepatier blocks the NS3 / 4A and NS5A proteins.

The two new medicines facilitate the treatment of patients suffering from chronic HCV infection without the necessity for interferons, medicines which are related to poor tolerability and potentially serious side effects that eliminate the possibility of treatment in a significant number of HCV patients.

Epclusa contains sofosbuvir, which is already approved under the name Sovaldi, and an important HCV protein inhibitor as a combination therapy with ledipasvir under the name Harvoni, as well as velpatasvir.

"The fixed dose combination of the direct-acting antivirals fights against all six genotypes of the virus."

The fixed dose combination of the direct-acting antivirals fights against all six genotypes of the virus.

Zepatier, on the other hand, comprises two unique HCV protein inhibitors, elbasvir and grazoprevir.

The fixed-dose combination of these direct-acting antivirals helps fight against genotypes I and IV of the disease.

The opinions adopted by the Committee for Medicinal Products for Human Use (CHMP) in May this year will be sent to the European Commission (EC) for the adoption of decisions on EU-wide marketing authorisations for Zepatier and Epclusa.


Image: Hepatitis C virus. Photo: courtesy of BruceBlaus.