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Gilead hepatitis C drug gets approval from China Drug Administration

Foster City, Calif.'s Gilead Sciences Inc. said the China Drug Administration approved its drug Epclusa for two hepatitis C virus indications.

The drug, a combination of sofosbuvir and velpatasvir, was approved to treat adults with genotype 1-6 chronic hepatitis C virus infection. A combination of Epclusa plus ribavirin was also approved to treating HCV and decompensated cirrhosis — complications related to the scarring of their liver.

Hepatitis C, which spreads through contaminated blood and causes liver inflammation, is China's fourth most commonly infectious disease, Gilead said.

The CDA approval is based on five international phase 3 studies. The U.S. Food and Drug Administration and the European Commission approved Epclusa in 2016.

Gilead sells sofosbuvir under the brand Sovaldi.