FDA panel recommends approval of Novo degludec insulin Thu Nov 8, 2012 6:22pm EST (Reuters) - An advisory panel to the U.S. Food and Drug Administration on Thursday voted to recommend approval of Danish drugmaker 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 large 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 large 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. "Currently available basal insulins are imperfect and don't last 24 hours," said Dr. David Cooke, a panel member who is an associate professor of pediatrics at Johns Hopkins University School of Medicine. "A true basal that gives constant coverage for 24 hours would make a difference," Cooke said. Dr. Kenneth Burman, chief of endocrinology at Washington Hospital Center in Washington, D.C., said the drug's duration of action "seems unique. Instead of a 12-hour half life, it's probably 24 hours. 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. But the panel voted 8 to 4 to recommend degludec's approval, despite concerns about heart safety, saying its benefits appear to outweigh its risks. The FDA usually follows the recommendations of its advisory panels. A large trial with thousands of patients could reliably assess its safety, but could take a number of years to complete. The panel did not vote on whether the trial should be conducted before, or after, degludec is approved. This story was refiled to remove extraneous word "regs" from the first paragraph Reporting By Ransdell Pierson; editing by Jim Marshall