written by Michael O’Leary
Last week an FDA advisory panel recommended degludec, a once-daily injectable insulin, be approved by the FDA, but will require Novo Nordisk to conduct additional trials to assess the heart risk that may be posed by the drug.
As reported by Fierce Biotech, Reuters and others the outside panel of non-FDA medical experts recommended approval by an 8-4 vote, but unanimously voted to require additional studies to assess the heart risk.
(published site)
In recommending approval, the panel looked at the combined study results of 16 clinical trials Novo has conducted involving more than 9,000 people with type 1 diabetes and those with type 2 diabetes who are no longer able to control their blood sugar levels with other medications alone.
The panel was impressed by the effectiveness of the drug’s long-acting characteristics, which allow people to take it at a different time of the day should they miss their dose at their regular time, which is not the case with current drugs.
Panel member Dr. David Cook who is an associate professor of pediatrics at Johns Hopkins University School of Medicine told Reuters that current basal insulins don’t last 24-hours, and one that does give constant coverage for 24 hours would make a difference.
In one study designed to demonstrate the flexibility of degludec showed effectiveness comparable to Sanofi’s Lantus. As presented at the American Diabetes Association meeting in 2010 and reported by Diabetes In Control.com, dosing that allowed patients to go days without a shot using the flexible insulin degludec schedule wasn’t any less effective for glucose control than once-daily dosing. Both degludec and Lantus lowered A1c by 1.3 percent to an average of 7.2 percent.
The studies the panel evaluated were designed to test blood sugar control, but a small number of people experienced heart-related events, such as heat attacks or chest pain. There were not enough of these events for the panel to hold up the drug’s approval, but there was enough concern for them to recommend unanimously that studies be done to specifically look at heart risks.
Heart risks have been of greater concern with diabetes drugs since heart problems occurred with GlaxoSmithKline’s Avandia, which eventually caused the drug to be withdrawn from the market.
If approved, Novo intends to market degludec under the brand name Tresiba. The European Medicines Agency has already recommended approval and it has been approved for marketing in Japan.