Vertex’s Orkambi Approved With Broad Label For Cystic Fibrosis
This article was originally published in The Pink Sheet Daily
Quick launch is planned, with firm having prepared ‘at risk of having a successful approval’ – patient screening and reimbursement shepherding are early areas of focus.
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US FDA plans to open a manufacturing research lab near its White Oak headquarters in 2021 to facilitate evaluation of novel manufacturing technology.
Sales of key cystic fibrosis drugs will jump in western economies over the next decade, driven by strong uptake of high-cost CFTR modulator therapies and longer use as life expectancies improve, according to a new report by Datamonitor Healthcare.
Although a study testing a combo of the company's cystic fibrosis drug Kalydeco and the investigational VX-661 in patients with minimal CFTR function was ended due to futility, Vertex is on pace for a 2017 filing of the combo in three other CF subpopulations.