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Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the FDA seeking approval for telaprevir, Vertex’s investigational treatment for people with hepatitis C. The NDA submission is supported by results from three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before but did not achieve a sustained viral response (SVR, or viral cure). The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.
Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex said, This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated. 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.
