Degludec Review Could Lead To New CV Safety Requirements For Insulins
During an advisory committee review of Novo Nordisk’s long-acting basal insulin, FDA raises concerns about a cardiovascular risk signal seen across a meta-analysis of clinical trials, although insulins have been excluded from CV safety requirements for type 2 diabetes drugs.
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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.