Trials & Filings

CF Update from Vertex

Programs in process for cystic fibrosis as company plans to advance next-gen corrector

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Vertex Pharmaceuticals has provided a comprehensive update on recent progress in its R&D activities in cystic fibrosis (CF): The TRAFFIC and TRANSPORT Phase III studies of lumacaftor (VX-809) in combination with Kalydeco (ivacaftor) in people with two copies of the F508del mutation are fully enrolled. Data from these studies are expected in mid-2014, and Vertex plans to submit an NDA in the U.S. and an MAA in Europe in the second half of 2014 for the combination of lumacaftor and ivacaf...

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