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FDA Panel Recommends Approval Of Novo Nordisk A/S Degludec Insulin-Reuters


Thursday, 8 Nov 2012 06:46pm EST 

Reuters reported that an advisory panel to the U.S. Food and Drug Administration on November 08, 2012 voted to recommend approval of Novo Nordisk's new ultra-long-acting insulin degludec, despite signals of possible cardiovascular risk. The panel of outside medical experts unanimously recommended that the Company undertake a study, possibly after the basal insulin is approved, to verify heart safety of the once-daily drug. Panel members said during an all-day meeting that they were concerned about a trend toward higher incidence of cardiovascular events with degludec than other drugs in 16 clinical trials, even though the difference was not statistically significant. But they expressed enthusiasm for degludec's 24-hour duration of action, saying it was perhaps unmatched by other drugs and would allow patients to take the insulin at a different time of the day if they missed taking it at their usual time. The panel began weighing the benefits and risks of the medicine two days after FDA staff members said combined data from the 16 studies suggest degludec may increase the risk of cardiovascular death, non-fatal heart attacks and strokes and unstable angina, compared to standard insulins. Moreover, FDA staff reviewers had suggested degludec may offer no strong advantage over other drugs in avoiding hypoglycemia -- dangerously low blood sugar levels that are a common side effect of insulin. Some members of the FDA advisory panel echoed those concerns on November 08, 2012. 

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