FDA Approves Gilead’s New Drug For Chronic Hepatitis C Virus Infection

The Food and Drug Administration Dec. 6 approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection.

Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon, the agency said. The drug is marketed by Gilead Sciences Inc., which is based in Foster City, Calif.

The FDA said that Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The Food and Drug Administration Safety and Innovation Act, passed in July 2012, gave the FDA the ability to designate a drug ...