Dapagliflozin Passes CV Safety Test For Now; FDA Panel Eyes Outcomes Study
Members of the Endocrinologic and Metabolic Drugs Advisory Committee endorse approval of Bristol/AstraZeneca’s SGLT-2 inhibitor, believing that the ongoing 17,000-patient DECLARE trial will supply needed answers around cardiovascular and bladder cancer concerns.
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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.
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.
Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.