Drug Overview
Multiple combination products based on the same active compound are known as a drug franchise. Franchises exist to give physicians, as well as patients, different treatment choices and to help with issues such as pill burden and compliance. These factors are of particular importance in dyslipidemia as many patients are likely to be taking a variety of medications, requiring various pills and dosing regimens. The Zetia (ezetimibe; Merck & Co) franchise offers combination preparations involving Zetia and the statin drugs Lipitor (atorvastatin calcium; Pfizer/Astellas/Menarini/Almirall) and Zocor (simvastatin; Merck & Co), based on their complementary mechanisms of action.
Despite demonstrating a small but significant improvement in cardiovascular (CV) outcomes in the IMPROVE-IT trial, the US Food and Drug Administration (FDA) rejected Zetia’s label expansion for the reduction of CV risk. This decision followed a negative recommendation from the FDA’s advisory committee, which questioned the robustness of the results and the clinical meaningfulness of the benefit. Recent entry of generic versions of all three drugs in the Zetia franchise is expected to result in the erosion of franchise sales. Zetia’s position is further threatened by the market entry of the proprotein convertase subtilisin/kexin type 9 inhibitors, which have shown superior low-density lipoprotein cholesterol-lowering abilities in Phase III clinical trials.
Multiple combination products based on the same active compound are known as a drug franchise. Franchises exist to give physicians, as well as patients, different treatment choices and to help with issues such as pill burden and compliance. These factors are of particular importance in dyslipidemia as many patients are likely to be taking a variety of medications, requiring various pills and dosing regimens. The Zetia (ezetimibe; Merck & Co) franchise offers combination preparations involving Zetia and the statin drugs Lipitor (atorvastatin calcium; Pfizer/Astellas/Menarini/Almirall) and Zocor (simvastatin; Merck & Co), based on their complementary mechanisms of action.
Despite demonstrating a small but significant improvement in cardiovascular (CV) outcomes in the IMPROVE-IT trial, the US Food and Drug Administration (FDA) rejected Zetia’s label expansion for the reduction of CV risk. This decision followed a negative recommendation from the FDA’s advisory committee, which questioned the robustness of the results and the clinical meaningfulness of the benefit. Recent entry of generic versions of all three drugs in the Zetia franchise is expected to result in the erosion of franchise sales. Zetia’s position is further threatened by the market entry of the proprotein convertase subtilisin/kexin type 9 inhibitors, which have shown superior low-density lipoprotein cholesterol-lowering abilities in Phase III clinical trials.
Table of Contents
OVERVIEW
LIST OF FIGURES
LIST OF TABLES
