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FDA’s Approval of Experimental Insulin Comes with Concerns

Filed November 14th, 2012 Laurie

A U.S. Food and Drug Administration (FDA) advisory panel endorsement of an experimental insulin known as Tresiba (degludec) made by Novo Nordisk has analysts concerned for the heart health of patients.

The panel voted to endorse Tresiba (degludec) insulin 8-4, despite documentation showing a meta analysis of the drug indicated it had an “increased risk of cardiovascular death, non-fatal MI, non-fatal stroke and unstable angina relative to comparators.” The panel voted 12-0 in favor of a cardiovascular outcomes study, saying more investigation was necessary, MM&M reported.

But analysts say that is not enough to protect patients. Leerink Swann analyst Seamus Fernandez wrote that he believed the best solution would be “approval with a disadvantaged label citing potential CV safety risk with a post-approval CV outcomes study.” One particular concern is Novo’s hypoglycemia data, which showed no advantage over the competing insulin, Lantus, in controlling blood sugar overnight. Fernandez said that since patients are less likely to check their glucose levels at night, Novo’s data for nocturnal hypoglycemia is less reliable, MM&M explained. The FDA is under no legal obligation to follow the advisory panel’s suggestions, and the agency hasn’t set a date for when it will release its decision.

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