Vertex Granted Speedy FDA Review

Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: [[ticker: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.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.