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Sanofi and Regeneron get off the approval starting blocks with alirocumab

This article was originally published in Scrip

Executive Summary

Sanofi and Regeneron have announced that the EMA has accepted for review their MAA for the PCSK9 inhibitor Praluent (alirocumab) just days after announcing positive data for a monthly dosing schedule for the investitgational hypercholesterolemia product (, 9 January 2015). The companies also confirmed that a BLA was indeed filed at the US FDA in the fourth quarter of 2014, as had been expected.


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