Cambridge, Mass.-based Vertex Pharmaceuticals Inc. reports it has completed a new drug application seeking regulatory approval for telaprevir, a hepatitis C drug candidate. Included in the submission is a request that the Food and Drug Administration reduce its review time from 10 months to six months. "This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated," says a statement from Matthew Emmens, the company's chair, president, and CEO. "We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure."
11/23/10
UNITED STATES: Vertex Submits Application for Hepatitis C Drug
Source: Boston Globe (11.23.10); Courtesy of the CDC National Center for HIV, STD, and TB Prevention