U.S. FDA panel backs Gilead hepatitis C drug sofosbuvir

Reuters

By Toni Clarke

WASHINGTON, Oct 25 (Reuters) - A federal advisory panelrecommended on Friday that the U.S. Food and Drug Administrationapprove Gilead Sciences Inc's experimental hepatitis Cdrug sofosbuvir, paving the way for a treatment that is moreeffective than current therapies and takes less time.

The FDA advisory panel voted 15 to 0 in favor of approval ofthe drug in patients with two variants of the liver-damagingdisease - genotype 2 and genotype 3 - in combination with anexisting treatment, ribavirin.

If approved, it will be the first all-oral treatment forgenotypes 2 and 3, obviating the need for the injectable druginterferon, which can cause debilitating side effects. Panelistscalled 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 CentralArkansas Veterans Healthcare Service.

The panel also voted unanimously to approve the drug inpatients with genotype 1 and genotype 4 variants in combinationwith ribavirin and interferon in patients who have not receivedprior therapy.

Genotype 1 accounts for roughly 70 percent of hepatitis Ccases. The FDA is not bound to follow the advice of its panelsbut typically does so.

"We'd already built in 100 percent chance of approval intoour valuation for the company," said Karen Andersen, an analystat Morningstar. "Gilead is still really in the prime positionlooking ahead in the hepatitis C market."

Panelists also appeared to support the use of sofosbuvir inpatients who failed prior treatment, even though the company haslittle hard data to support such a claim.

"I did think there was a surprise upside result by the endof the panel," said Michael Yee, an analyst at RBC CapitalMarkets.

Bristol-Myers Squibb Co and Abbvie Inc haveadvanced all-oral clinical trial programs in late-stagedevelopment, using a variety of so-called direct actingantivirals, which directly interfere with the virus's ability toreplicate. But Gilead is widely seen to be in the lead.

Chronic hepatitis C affects at least 3 million people in theUnited States, according to the U.S. Centers for DiseaseControl.

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

Current standard treatments for genotype 1 often include aprotease inhibitor. These are oral drugs that include Merck & CoInc's Victrelis and Vertex Inc's Incivek.

Gilead acquired sofosbuvir, known as a nucleotide analogueinhibitor, with its $11 billion purchase of Pharmasset Inc in2012.

Panelists urged Gilead to make the drug available to othercompanies to study in combination with other oral regimenswaiting in the wings.

Bristol-Myers is expected to present data from a late-stageclinical trial of its interferon-free treatment of genotype 1patients at next month's meeting of the American Association forthe Study of Liver Diseases in Washington, D.C.

The FDA is due to rule on whether to approve the drug byDec. 8.

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