Prescription Drugs

Vertex Pharma files Telaprevir NDA to FDA

Vertex Pharmaceuticals USA has submitted a NDA (new drug application) for the approval of Telaprevir treatment for people with hepatitis C to the US Food and Drug Administration. The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months.

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.
The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.
Telaprevir co-developed by Vertex and Johnson & Johnson. In a randomized controlled trial of patients in whom standard treatment with peginterferon alfa-2a and ribavirin had failed, repeat treatment with the addition of telaprevir was more likely to have a sustained response than repeat treatment with peginterferon alfa-2a and ribavirin alone.

Telaprevir

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