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Reuters Health Information (2013-10-25): U.S. FDA panel backs sofosbuvir for hepatitis C

Regulatory

U.S. FDA panel backs sofosbuvir for hepatitis C

Last Updated: 2013-10-25 16:30:07 -0400 (Reuters Health)

WASHINGTON (Reuters) - A federal advisory panel recommended on Friday that the U.S. Food and Drug Administration approve Gilead Sciences Inc's experimental hepatitis C drug sofosbuvir, paving the way for a treatment that is more effective than current therapies and takes less time.

The FDA advisory panel voted 15 to 0 in favor of approval of the drug in patients with two variants HCV genotype 2 and genotype 3, in combination with ribavirin.

If approved, it will be the first all-oral treatment for genotypes 2 and 3, obviating the need for the injectible drug interferon, which can cause debilitating side effects.

Panelists called the vote "historic" and a "game-changer."

"Our patients have been waiting for this for a long time," said Dr. Curt Hagedorn, chief of medicine service at the Central Arkansas Veterans Healthcare Service.

The panel also voted unanimously to approve sofosbuvir in patients with genotype 1 and genotype 4 variants in combination with ribavirin and interferon in patients who have not received prior therapy. Genotype 1 accounts for roughly 70% of hepatitis C cases.

Chronic HCV affects at least 3 million people in the United States, according to the U.S. Centers for Disease Control and Prevention.

Analysts on average expect Gilead's drug to generate sales of $1.73 billion in 2014, according to Thomson Reuters data.

Panelists urged Gilead to make sofosbuvir available to other companies to study in combination with other oral regimens waiting in the wings.

The FDA is not bound to follow the advice of its panels but typically does so.

The FDA is due to rule on whether to approve sofosbuvir by Dec. 8.

 
 
 
 
                 
 
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