A Vote (and a Warning) for a New Insulin
Insulin degludec (Tresiba), an ultra-long-acting insulin, received a vote for approval from a Food and Drug Administration advisory committee in November. (The FDA usually follows panel recommendations.) Novo Nordisk’s new drug lasts longer than insulin glargine (Lantus) and insulin detemir (Levemir), and doesn’t require dosing at the same time each day. But despite advisory panel members’ enthusiasm over the flexibility that insulin degludec would give people with diabetes, they worried about its safety, unanimously voting to require a trial to determine whether the drug raises the risk of heart disease. The panel didn’t vote on whether the trial should be conducted before the insulin is cleared by the FDA.