Novo Nordisk (NYSE:NVO) announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its new once-weekly basal insulin icodec, aimed at treating diabetes mellitus.

The letter highlighted requests related to the manufacturing process and the type 1 diabetes indication that must be addressed before the application can proceed.

The company say it is working closely with the FDA to identify the next steps needed to complete the review so they can provide this novel treatment option to adults living with diabetes.

Novo Nordisk says it does not expect to meet the FDA’s requests within 2024.