Can Sanofi Catch Up With Amgen Now That Praluent Has CV Risk-Reduction Claim?

Apr 29 2019

• By Joseph Haas

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ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.

Risk Reduction words on puzzle pieces to illustrate a solution or mitigation of danger, hazard, liability or injury — Like Repatha, Praluent now has CV outcomes data in its US label.

With cardiovascular risk-reduction language added to the product’s US label, Sanofi and partner Regeneron Pharmaceuticals Inc. hope Praluent is now better positioned to compete with rival PCSK9 inhibitor Amgen Inc.’s Repatha, which nabbed an outcomes claim in December 2017. Further, the two companies may now hold an edge over the better-selling Repatha as the label update also includes data suggesting an all-cause mortality benefit.

The US FDA cleared the label expansion on 26 April, the same day Sanofi reported that Praluent (alirocumab) yielded disappointing...

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