Novo’s Insulin Degludec Faces Advisory Cmte. Scrutiny On Hypoglycemic Benefit, CV Safety
This article was originally published in The Pink Sheet Daily
In briefing documents for the Nov. 8 panel review, FDA suggests the clinical trial data do not support Novo Nordisk’s assertion of a hypoglycemia advantage with its new long-acting insulin. Agency also raises concerns about a meta-analysis suggesting an increased cardiovascular risk.