Vertex Gets Quick FDA Approval Of Kalydeco; Prices New CF Drug At $294,000 Per Year
This article was originally published in The Pink Sheet Daily
Kalydeco, an oral CFTR potentiator, becomes the first approved drug to address the underlying cause of cystic fibrosis, rather than just treating the disease’s symptoms.
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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.
Orkambi is the first combo drug to be priced lower than solo therapy with one of its components, but it stands to increase Vertex’s patient base exponentially.
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.