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The SHARP “Approval”: Merck Gets Vytorin Labeling Change, But Not The CV Outcomes Claim It Sought

 
• By Sue Sutter

FDA opted against a new indication for the ezetimibe/simvastatin combination because the SHARP trial in chronic kidney disease patients did not assess the independent contributions of each drug on the observed effect. There was no indication at a November advisory committee review that issues related to the “combination rule” would pose a barrier to a new claim.

FDA’s recent decision to add the results of the SHARP study in chronic kidney disease patients to the labeling for Merck & Co. Inc.’s Vytorin (ezetimibe/simvastatin), but not to allow a claim for cardiovascular risk reduction based upon those results, begs the regulatory question of what constitutes an “approval.”

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