Sanofi/Regeneron Get Reprieve: Praluent Can Stay On Market For Now
Federal Circuit stays injunction that would have halted sales of the PCSK9 inhibitor on Feb. 21; stay extends through appeal of injunction and patent verdict.
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While sales of Sanofi/Regeneron's Praluent, which will remain on the US market for the time being, could see a small boost, larger commercial challenges in the PCSK9 category linger.
Three-judge US federal appellate panel focuses on evidentiary rulings and patent validity in the dispute between Repatha marketer Amgen and Sanofi/Regeneron; lower court’s permanent injunction barring sales of Praluent did not come up at oral arguments.
After reporting yet another quarter of disappointing sales, Amgen and Sanofi/Regeneron look forward to better performance now that outcomes data are out, but payers may not be up for easing hurdles enough.