PCSK9 Sponsors Looked For Regulatory Advantages In Race To Market
Executive Summary
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.
You may also be interested in...
Gilead Buys Its Third Priority Review Voucher, But Is The Mania Over?
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.
How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say
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.
Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack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.