EC approves Gilead's sofosbuvir

The European Commission approved Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat chronic HCV in adults, including patients co-infected with HIV. Sovaldi is approved in combination with ribavirin for 24 weeks as an all-oral therapy to treat HCV genotypes 2 and 3 infection. Sovaldi is approved in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 4, 5 and 6 infection; the all-oral regimen is indicated for these patients when they are ineligible or intolerant to pegylated interferon. The approval also covers use of Sovaldi in combination with ribavirin for patients with HCV who are awaiting liver transplantation.

FDA and Health Canada approved the nucleotide analog HCV NS5B polymerase inhibitor in December. Sovaldi is approved in the U.S. and Canada in combination with ribavirin to treat HCV genotypes 2 and 3 infection. It is also approved in combination with ribavirin and pegylated interferon to treat HCV genotypes 1 and 4 infection. Sovaldi's U.S. label specifies Sovaldi may be used in combination with ribavirin alone in HCV genotype 1 infection patients who are interferon ineligible (see BioCentury Extra, Dec. 6, 2013). ...