The FDA released a guidance making recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. The guidance titled “Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes was issued for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes. The guidance recommends that sponsors: establish independent cardiovascular endpoint committees to adjudicate cardiovascular events, and design clinical trials so that meta-analysis can be performed, providing an appropriate protocol that describes the statistical methods for meta-analysis.
SOURCE: FDA Notice.
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