FDA Panel Questions Role Of CV Safety Meta-Analyses At Dapagliflozin Review
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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AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) finally clears FDA, and without a black box warning on bladder cancer risk – allowing the drug to compete with J&J’s first-to-market Invokana.
Agency finally clears AstraZeneca/Bristol Myers-Squibb’s SGLT-2 inhibitor Farxiga (dapagliflozin), but with post-marketing strings attached.
AstraZeneca will acquire all of Bristol’s interests in their current diabetes alliance. In doing so, AZ believes its geographic reach and scale in assets and capabilities position it to succeed, while Bristol retreats from diabetes to focus on specialty biologics, notably its PD-1 franchise.