Leveraging Competitor Information to Predict Efficacy of a Novel Drug Formulation

Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support developing a fixed-dose combination of ezetimibe and atorvastatin. The sponsor needed to determine the optimal design for clinical equivalence (CE) trials to evaluate a fixed-dose combination (FDC) of two previously approved drugs, ezetimibe and atorvastatin. Certara Strategic Consulting scientists used model-based meta-analysis to understand the impact of dosing regimen and formulation on low-density-lipoprotein cholesterol (LDL-C) levels, to predict the impact of changes in exposure for ezetimibe+atorvastatin FDC on efficacy, and inform the design of CE trials. Insights from the model’s predictions from simulations supported reducing the sample size for the CE trials by 17% while still maintaining a 90% probability of success thus saving time and decreasing cost.

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