Vertex Granted Speedy FDA Review

1/20/11

Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) said today that the FDA has granted the company’s request for a priority review, meaning that the agency will take six months (instead of the usual 10) to analyze the company’s application to market telaprevir as a new treatment for hepatitis C. The FDA sometimes grants such faster reviews for potentially lifesaving or groundbreaking new therapies. Since Vertex filed its application on November 23, that means the FDA deadline to make a decision on the drug is set for May 23. Vertex is in a race to the market with another protease inhibitor for hepatitis C—Merck’s boceprevir—which also has been granted a six-month expedited review by the FDA.

By posting a comment, you agree to our terms and conditions.