Key result
New FDA regulations requiring cardiovascular risk assessment for type 2 diabetes treatments will necessitate larger, more comprehensive development programs and post-approval safety outcome studies.
Highlights the impact of FDA requirements for cardiovascular safety assessments on the development of novel type 2 diabetes treatments.
New FDA mandates expand diabetes drug trial scope and post-approval studies; leaves open optimal designs for efficient cardiovascular safety assessment.
L ingering questions related to cardio-vascular (CV) safety of type 2 di-abetes treatments resulted in new U.S. Food and Drug Administration (FDA) regulations requiring careful assessment of CV risk. These new requirements will provide the medical community with robust data to estimate CV risk associated with new therapeutic agents. To meet these requirements, phase 2 and 3 devel-opment programs will need to be larger and more comprehensive and will in-clude high-risk patients. In addition, it is likely that most (if not all) newly approved drugs will be required to con-duct post-approval CV safety outcome studies. The purpose of this article is to
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Hirshberg et al. (2011) conducted a review in Type 2 diabetes. Novel Antidiabetes Drugs was evaluated. New FDA regulations requiring cardiovascular risk assessment for type 2 diabetes treatments will necessitate larger, more comprehensive development programs and post-approval safety outcome studies.
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