Vertex Says FDA Will Rule on Telaprevir By May 23

From Associated Press (January 20, 2011)


CAMBRIDGE, Mass. -- Vertex Pharmaceuticals Inc. said Thursday that regulators in the U.S. and Canada will speed their reviews of its drug candidate telaprevir, meaning the hepatitis C therapy could be approved months earlier than usual.

Vertex said the Food and Drug Administration will do a six-month priority review on telaprevir, meaning the agency expects to make a decision by May 23. Typical FDA reviews last about 10 months, starting from the date the drug maker files for approval.

The Therapeutic Product Directorate of Health Canada will take six to nine months to make its decision on telaprevir, Vertex said. Standard reviews in Canada take about a year and a half.

Telaprevir is already receiving an accelerated review in Europe. Analysts believe Vertex could get billions of dollars in annual revenue from telaprevir, the first in what could be a series of new treatments for hepatitis C.

Telaprevir and Merck & Co.’s drug boceprevir are more effective than older therapies in controlling the viral liver disease.
 

Posted: January 2011


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