Vertex Pharma said that the NDA submission for Telaprevir 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.
Vertex Pharma chairman, president and CEO Matthew Emmens said that this submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated.