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

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...