PCSK9 Sponsors Looked For Regulatory Advantages In Race To Market
Both Sanofi/Regeneron and Amgen coveted priority review for their LDL-cholesterol-lowering agents, but the Praluent sponsors' purchase of a voucher gave them the definitive edge. Amgen found no help in the breakthrough program, with FDA twice denying designation requests for Repatha, review documents show.
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Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.
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.
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.