Ilaris Complete Response Letter Raises Questions About The Validity of Priority Review Vouchers
What’s a Priority Review Voucher worth? That’s a complicated question now that the first voucher used on an application, from drug maker Novartis AG for Ilaris (canakinumab), has received a complete response letter from US regulators.
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The agency seeks more clinical data on canakinumab in refractory patients after an advisory committee meeting that focused on the drug's potential risks.
FDA’s innovative priority review voucher, intended to incentivize the development of new drugs for neglected diseases, may actually have created a hurdle in some cases.
There's no real market for priority review vouchers; indeed, it seems like there is only one voucher in existence at the moment – Novartis' coupon from the Coartem approval.