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FDA reviewers back Gilead's sofosbuvir

October 23, 2013 11:55 PM UTC

FDA reviewers said data support the use of sofosbuvir ( GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) in combination with ribavirin to treat HCV genotypes 2 and 3 infection -- making it potentially the first all-oral, interferon-free regimen to be approved. The reviewers also said data support sofosbuvir in combination with ribavirin and pegylated interferon to treat HCV genotypes 1 and 4 infection. They said there are insufficient data to make a recommendation on the regimen in patients with the HCV genotypes 5 or 6 infection. The reviewers said "no major safety issues associated with sofosbuvir" have been identified.

The details came in HCV NS5B polymerase inhibitor is under Priority Review, with a Dec. 8 PDUFA date. Sofosbuvir also is under accelerated assessment in the EU for the same indications. An accelerated assessment shortens the review period to 150 days from 210. ...