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FDA panel unanimously backs Gilead's hepatitis C drug sofosbuvir
October 25, 2013 / 6:51 PM / 4 years ago

FDA panel unanimously backs Gilead's hepatitis C drug sofosbuvir

WASHINGTON, Oct 25 (Reuters) - A federal advisory panel recommended on Friday that U.S. health regulators approve Gilead Sciences Inc’s experimental hepatitis C drug sofosbuvir.

The panel voted 15 to 0 in favor of approval of the drug in patients with two variants of the liver-damaging disease - genotype 2 and genotype 3 - in combination with an existing treatment, ribavirin.

If approved, it would be the first all-oral treatment for genotypes 2 and 3.

The panel also voted unanimously to approve the drug in patients with genotype 1 and genotype 4 variants in combination with ribavirin and the injectible drug interferon in patients who have not received prior therapy.

Genotype 1 accounts for roughly 70 percent of hepatitis C cases. The FDA is not bound to follow the advice of its panels but typically does so.

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