FDA Panel To Weigh Dapagliflozin Bladder Cancer, CV Safety Questions
This article was originally published in The Pink Sheet Daily
Executive Summary
Endocrinologic and Metabolic Drugs Advisory Committee will revisit concerns first discussed at 2011 meeting about bladder cancer risk with Bristol/AstraZeneca’s diabetes drug. Cardiovascular meta-analysis continues to suggest benefit but FDA questions what to make of “discordant” results from two studies in patients with CV disease.
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