FDA Used Invokana Review To Reflect On Diabetes CV Risk Policy
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Agency officials viewed the review of canagliflozin – the first program started after the 2008 outcomes trial requirement – as a chance to look at lessons learned since the policy went into effect.
You may also be interested in...
Nothing To SAVOR For Bristol/AZ From Onglyza Results
Bristol and AstraZeneca announced mixed results from a post-marketing study for their diabetes drug Onglyza that will likely have no commercial ramifications for the drug, which has been a disappointment since its launch in 2009.
Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety
Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.
Avandia Panel Wants Another Trial: Pipe Dream Or Post-market Benchmark?
Designed with complex, multi-variate statistics, an observational trial could determine the CV risk of rosiglitazone compared to other diabetes drugs, an advisory committee member suggests during the latest assessment of Avandia.