Recent Round Of Obesity Reviews Suggests CV Safety Standards Have Come Into Focus
The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion.
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Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel
There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.
FDA Clears Belviq With Post Hoc Finding Of Less Than Double Placebo CV Risk
In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.
Belviq Gains FDA Approval For Weight Loss, But DEA Review Will Delay Launch
With a July 17 user fee date, Vivus’ obesity drug Qnexa could beat Arena Pharmaceuticals’ Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.