Insulin Degludec’s CV Risks Can Be Studied Post-Approval, Cmte. Says

The majority of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agrees the potential advantages of Novo Nordisk’s long-acting basal insulin justify approval before a cardiovascular risk signal seen in a meta-analysis is fully explored in a dedicated outcomes study.

Novo Nordisk AS’ long-acting basal insulin degludec should be approved despite the presence of a potentially concerning cardiovascular safety signal, an FDA advisory committee said Nov. 8.

The Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 that efficacy and safety data support marketing of Tresiba (insulin degludec)...

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