Another Drug Approved for Treating Chronic Hepatitis C
Sovaldi is the third drug with breakthrough therapy designation to receive FDA's approval.
The U.S. Food and Drug Administration on Dec. 6 approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection, stating in a news release that it 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."
"Today's approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. The agency had approved Olysio (simeprevir) on Nov. 22.
Sovaldi is marketed by Gilead, based in Foster City, Calif.