Vertex's CF Three-Drug Combo Excels In Phase III, But Filing Depends On Second Regimen's Results

 
• By Joseph Haas
  
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Vertex duplicated promising efficacy observed in Phase II for its cystic fibrosis triple combo that includes VX-659, but wants to see data expected in early 2019 for a triplet containing VX-445 before filing for approvals.

Cystic Fibrosis, Medical Concept with Pills, Injections and Syringe. Cystic Fibrosis - Printed Diagnosis with Blurred Text. 3D Render.

Market analysts agreed across the board that Vertex Pharmaceuticals Inc. reported data at the upper end of what could be expected from a pair of Phase III trials evaluating a three-drug combination regimen for cystic fibrosis (CF) that includes experimental CFTR corrector VX-659. However, regulatory filings are on hold until the company also sees data from studies of a different triple combo using VX-445.

Vertex already is the market-leader in cystic fibrosis with Kalydeco (ivacaftor) and the two-drug combination regimens Orkambi (ivacaftor/lumacaftor) and Symdeko...

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