European Committee Recommends Approval of Two Hepatitis C Drugs

A committee of the European Medicines Agency has recommended approval of two new combination drugs to treat chronic hepatitis C infection, the agency announced.

 

The agency’s recommendation to grant marketing authorizations is a big step toward approval of both drugs, one made by pharmaceutical giant Merck and the other by Gilead Sciences of California. The recommendation still must go to the European Commission for final approval and, if affirmed, adoption of decisions to authorize marketing throughout the European Union, according to an EMA news release.

 

“Once the authorizations have been granted, decisions about price and reimbursement will take place at the level of each Member State considering the potential role/use of these medicines in the context of the national health system of that country,” states the EMA release.

 

Long-term infection of hepatitis C virus can lead to serious liver damage, cirrhosis and liver cancer. The blood borne virus affects between 0.4% and 3.5% of the population in various parts of the European Union and is the largest single cause of liver transplantation in the region, according to the release.

 

Both regimens awaiting final approval are direct acting antivirals, a new generation of drugs that have had high cure rates for the virus and “reshaped” the way the disease is treated, European officials noted in the release. The drugs work by blocking the action of proteins that the virus needs to replicate.

 

Both of the drug candidates were tested in clinical trials of 2000 patients or more and resulted in safety profiles that were considered generally favorable, the EMA release states. Overall cure rates were above 90%.

 

Merck’s regimen, called Zepatier, is a combination of the drugs elbasvir and grazoprevir, which targets the proteins NS3/4A and NS5A. In January, the FDA approved Zepatier for use with or without ribavirin to treat genotypes 1 and 4 of the hepatitis C virus, as did Canadian regulators, Merck noted in a news release.

 

Epclusa by Gilead targets the proteins NS5B and NS5A and is a once daily tablet that combines 400 mg of Sovaldi (sofosbuvir), a high profile hepatitis C drug already approved in several countries, and 100 mg of the drug velpatasvir, according to a Gilead release.

 

Gilead said the data submitted with the marketing application in Europe support the use of Epclusa in adults with genotypes 1 through 6 of the hepatitis C virus. The company also submitted a new drug application for the same drug in October to the US Food and Drug Administration and could find out at the end of June whether approval will be granted, according to the release.