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Gilead gets EU recommendation on hepatitis C drug
November 22, 2013, 05:00 AM The Associated Press

FOSTER CITY — Gilead Sciences said Friday that an advisory committee in the European Union is recommending that its hepatitis C drug Sovaldi receive marketing approval.

The drug is still being reviewed, but the recommendation could improve the chances it will be approved. Gilead says Sovaldi, or sofosbuvir, could be available in the EU during the first quarter of 2014.

The drug is also being reviewed by U.S. regulators. Food and Drug Administration advisers recommended approval in October, and the FDA is expected to make a decision on Sovaldi by Dec. 8.

Current treatments for hepatitis C can take up to a year of therapy and only cure about three out of four patients. Sovaldi is a pill taken once per day, and in clinical trials it cured up to 90 percent of patients infected with the most common form of the virus in just 12 weeks. Gilead acquired the hepatitis C drug in 2012 when it bought Pharmasset for $11.1 billion.

Shares of Gilead Sciences Inc. rose $3.37, or 4.7 percent, to $75 in morning trading after rising as high as $75.14, an all-time high.



Tags: gilead, sovaldi, hepatitis,

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