Gilead's Hepatitis C Drug One Step Closer to EU Approval
Today, Gilead Sciences 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.
The article Gilead's Hepatitis C Drug One Step Closer to EU Approval originally appeared on Fool.com.Fool contributor Chris Neiger has no position in any stocks mentioned. The Motley Fool recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 - 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.