(Reuters) – A panel of independent experts from the U.S. health regulator voted on Friday against the use of Novo Nordisk’s (NYSE:) weekly insulin in patients with type 1 diabetes due to the risk of low blood sugar.
A Food and Drug Administration panel voted 7 to 4 against the use of weekly basal insulin Icodec, saying its benefits do not outweigh the risks when used in adults with type 1 diabetes.
The comments come after FDA officials said Wednesday that using long-acting insulin increases the risk of low blood sugar in patients with type 1 diabetes who are more insulin-dependent.
Basal insulin helps regulate blood glucose levels throughout the day compared to bolus insulin, which controls the rise in blood glucose levels after meals.
Novo aims to be first to market with weekly insulin, offering a less frequent alternative to the millions of patients with type 1 and type 2 diabetes who now rely on multiple daily injections.
The weekly injection, branded Awiqli, was approved earlier this week for use in the European Union, the Danish drugmaker said on Friday.