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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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.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.