Praluent Panel To Focus On Indication Breadth Absent CV Outcomes Data
This article was originally published in The Pink Sheet Daily
FDA briefing documents for June 9 advisory committee review of Sanofi/Regeneron's alirocumab reflect concern that PCSK9 inhibitors, which lack long-term cardiovascular outcomes data, will be used in place of statins, an established class of drugs with extensive evidence of clinical benefit and long-term safety.
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Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.
With a well-defined mechanism of action and positive post hoc outcomes data, PCSK9 inhibitors possess a profile that raises the bar for other non-statin classes – CETP in particular.
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.