By Sriparna Roy and Mariam Sunny
(Reuters) -Advisors to the U.S. health regulator on Friday voted against the use of Novo Nordisk’s (NYSE:) weekly insulin in patients with type 1 diabetes because of the risk of low blood sugar.
The Food and Drug Administration’s panel of independent experts voted 7-4 and said the benefits of the weekly insulin icodec did not outweigh the risks.
Novo aims to be the first to market with a weekly insulin product, providing an alternative for patients with type 1 and type 2 diabetes who now rely on multiple daily injections.
“I am concerned that approving (insulin) icodec for use at this time with insufficient data could hinder further studies, which I believe are necessary for its safe use in type 1 diabetics,” says Cecilia Low Wang, the chairman of the panel.
The comments come after FDA staff on Wednesday noted the risk of low blood sugar in patients with type 1 diabetes, who are more dependent on insulin, and the lack of clinical data supporting Novo’s proposed methods for reducing the risks associated with hypoglycemia, a condition in which blood sugar levels fall below the standard range.
Novo said it will continue to work closely with the FDA to identify the next steps needed to bring the treatment to market.
The increase in hypoglycaemic events in type 1 diabetics could be a barrier for these patients, said Derren Nathan, analyst at Hargreaves Lansdown ahead of the panel meeting.
Barclays analyst Emily Field said it was likely the FDA would not recommend approval for type 1 patients, but that Novo could still seek approval for type 2 patients, which is a larger market.
Although the FDA generally follows the recommendations of its expert panel, it is not obligated to do so.
The weekly basal injection, branded Awiqli, was approved for use in the European Union earlier this week, the Danish drugmaker said Friday.
Basal insulin helps regulate blood sugar levels throughout the day, compared to bolus insulin, which controls the rise in blood glucose after meals.
Rival Eli Lilly (NYSE:) is also developing its own weekly insulin injection, efsitora.
