Concerns Prompt FDA to Seek More Info on Weekly Insulin

The US Food and Drug Administration (FDA) has issued a “complete response letter” to Novo Nordisk regarding its biologic license application for once-weekly basal insulin icodec for the treatment of people with diabetes, meaning that it requires more from the company before the product can be approved.

The FDA ‘s requests related to both the manufacturing process and the company’s requested indication for use in people with type 1 diabetes. On May 24, 2024, an advisory panel to the FDA voted seven to four that the potential benefits of once-weekly basal insulin don’t outweigh the increased risk for hypoglycemia in people with type 1 diabetes.

The panel didn’t address the product’s use in people with type 2 diabetes, in whom icodec has shown to be beneficial and without excessive hypoglycemia risk.

Novo Nordisk does not expect to be able to fulfill the FDA’s requests during 2024. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes,” said Martin Lange, the company’s executive vice president for development.

Novo Nordisk had submitted the application for insulin icodec to the FDA in April 2023. It is currently approved under the brand name Awiqli in the European Union, Canada, Australia, Japan, and Switzerland for the treatment of both types 1 and 2 diabetes and in China for the treatment of type 2 diabetes.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X: @MiriamETucker.