Where Could The Next Priority Review Voucher Come From?
There are 21 indications on the list of neglected tropical diseases that qualify for an FDA priority review voucher – an incentive to spur research in those areas – but there aren’t that many drugs in development.
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Priority review ticket might be used on Type 2 diabetes combo LixiLan, expected to be filed later this year.
Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.