(Reuters) – A panel of independent experts to the U.S. health regulator on Friday voted against the use of Novo Nordisk’s weekly insulin in patients with type 1 diabetes due to risks of low blood sugar.
The Food and Drug Administration’s panel voted 7-to-4 against the use of the weekly basal insulin icodec saying its benefits do not outweigh the risks when used in adult patients with type 1 diabetes.
The comments come after the FDA’s staff on Wednesday said the use of the long-acting insulin increases the risk of low blood sugar in type 1 diabetes patients, who are more insulin-dependent.
Basal insulin helps regulate blood glucose levels throughout the day compared to bolus insulin which manages blood glucose rise after meals.
Novo is aiming to be the first to hit the market with a weekly insulin product, offering a less frequent alternative for millions of patients with type 1 and type 2 diabetes who now depend on multiple daily injections.
The weekly injection, under the brand name Awiqli, has been approved earlier this week for use in the European Union, the Danish drugmaker said on Friday.
(Reporting by Sriparna Roy and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
