BioCentury
ARTICLE | Regulation

Triple standard in HCV

FDA panel: Include Vertex, Merck drugs in standard of care for HCV

May 2, 2011 7:00 AM UTC

An FDA panel's unanimous endorsement of HCV candidates Victrelis boceprevir from Merck & Co. Inc. and telaprevir from Vertex Pharmaceuticals Inc. last week was hardly a surprise. However, the panel's lukewarm reception for response-guided therapy with the protease inhibitors except in a subset of treatment-naïve patients means it could be another five years before the majority of patients can reduce or eliminate interferon-based treatment.

In two separate meetings last week, FDA's Antiviral Drugs Advisory Committee voted 18-0 to recommend approval of both boceprevir and telaprevir in combination with standard of care consisting of pegylated interferon and ribavirin...