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

Today, Gilead Sciences  (NASDAQ: GILD  ) 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. 

link


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2740167, ~/Articles/ArticleHandler.aspx, 9/22/2014 12:13:55 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement