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Gilead's Hepatitis C Drug One Step Closer to EU Approval

By Chris Neiger - Nov 22, 2013 at 3:48PM

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Gilead Sciences' Svaldi drug received a positive review from the Committee for Medicinal Products for Human Use, and now moves to the European Commission for approval.

Today, Gilead Sciences (GILD 0.80%) said that its new drug, called Svaldi, for the treatment of chronic hepatitis C, has received a "positive opinion" from the Committee for Medicinal Products for Human Use, or CHMP. The company said in a press release that the positive opinion means the CHMP approves Svaldi for treatment of the hepatitis C virus, or HCV, for adults "in combination with other agents." Gilead said that chronic HCV is a major cause of liver cancer in Europe and around the world.

"The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest," Gilead said in press release.

The CHMP's opinion of Sovaldi will now go to the European Commission for review. The Commission has the authority to approve drugs in 28 countries throughout the European Union. If the drug is approved by the Commission, it could be available in the EU by the first quarter of 2014.

The drug is also awaiting formal approval in the United States. Gilead said that an expert advisory committee of the U.S. Food and Drug Administration voted unanimously in late October that the available data supported approval. The FDA is expected to give a final decision about the drug on December 8. 


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