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FDA Panel Questions Role Of CV Safety Meta-Analyses At Dapagliflozin Review

Executive Summary

Agency’s 2008 guidance allows diabetes drug sponsors to exclude a threshold level of increased cardiovascular risk pre-approval through a meta-analysis of clinical trials; however, panelists reviewing Bristol/AstraZeneca’s SGLT-2 inhibitor questioned the usefulness of meta-analyses when they are based primarily upon short-term studies in patients unlikely to have events.

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