Zetia/Lipitor Combo’s Ongoing Clinical Equivalence Trials May Address FDA’s Data Request, Merck Says
This article was originally published in Pharmaceutical Approvals Monthly
FDA did not accept the company’s bioequivalence arguments supporting a fixed-dose combination of ezetimibe and atorvastatin. Merck believes new data that are expected to be available later this year may address the agency’s “complete response” letter.
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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.
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Citing a need for more data, the agency refuses to file an NDA for a pill combining ezetimibe (Zetia) and atorvastatin (Pfizer's Lipitor).