Dapagliflozin’s CV Profile Shines, But FDA Panel Review Falls On Cancer Concerns
The July 19 FDA advisory committee meeting on Bristol-Myers Squibb Co./AstraZeneca PLC's dapagliflozin reflects the hurdles facing type 2 diabetes drug sponsors even when cardiovascular safety concerns are taken out of the picture.
You may also be interested in...
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’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.
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.