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Praluent Panel To Focus On Indication Breadth Absent CV Outcomes Data

This article was originally published in The Pink Sheet Daily

Executive Summary

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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