EU regulators back approval of Gilead's new hep C drug

Saturday, May 28, 2016

An advisory panel to the European drug regulator recommended an approval for Gilead Sciences Inc's new drug combination to treat hepatitis C.

The European Medicines Agency (EMA) said on Friday that the Committee for Medicinal Products for Human Use backed Gilead's combination of velpatasvir and sofosbuvir. (

Sofosbuvir is at the centre of a patent battle between Gilead and Merck & Co Inc.

Gilead's combination treatment shares an active ingredient with Sovaldi, the company's blockbuster drug for hepatitis C.

The panel on Friday also recommended granting marketing approval for Merck's combination of elbasvir and grazoprevir to treat viral infection of the liver.

Merck is trying to catch up with Gilead, which dominates the market with a new generation of hepatitis C drugs that can cure over 90 percent of patients with the liver disease.

The EMA said Gilead's new combination therapy targeted all six genotypes of the virus, while Merck's combination drug targets only two kinds.

Gilead shares were little changed in pre-market trading on the Nasdaq.


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