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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.”

The regulatory action on Vytorin, which was preceded by an advisory committee review of the SHARP data and Merck’s request for a new indication, would appear to challenge the traditional...

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