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PCSK9 Inhibitors May Feel Effects Of FDA Judgment On IMPROVE-IT

 
• By Sue Sutter

Agency's decision on cardiovascular risk reduction claims for Merck's Zetia and Vytorin may serve as a regulatory barometer for the magnitude and robustness of effect that will be expected in outcomes studies for other LDL-C-lowering agents.

FDA's looming decision on efficacy labeling supplements for Merck & Co. Inc.'s Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) could foreshadow the challenges that sponsors of PCSK9 inhibitors and other lipid-altering treatments will face in securing cardiovascular risk reduction claims based on large outcomes studies.

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