FDA's Dapagliflozin Review To Focus On Hepatic Effects, Cancer Risks
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency will ask its Endocrinologic and Metabolic Drugs Advisory Committee to weigh these "unexpected" safety findings despite a clean cardiovascular profile for Bristol-Myers Squibb/AstraZeneca's first-in-class diabetes drug.
You may also be interested in...
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.
Stringent Hepatic Monitoring Urged For Diabetes Drug Clinical Trials
Difficulties surrounding the assessment of a possible case of drug-induced liver injury in the dapagliflozin clinical program show why more standardized hepatic monitoring is needed in future studies of type 2 diabetes agents, one of FDA’s outside advisors said.
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.