Novo Nordisk gets US Complete Response Letter for weekly basal insulin icodec

Bagsværd, Denmark, 10 July 2024 – Novo Nordisk has announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics License Application for once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. The FDA's letter includes requests regarding the manufacturing process and the indication for type 1 diabetes that must be addressed before the application review can be completed. Novo Nordisk is currently assessing the CRL's content and aims to collaborate closely with the FDA to meet these requirements. However, the company does not anticipate fulfilling these requests within 2024.

Martin Lange, Executive Vice President for Development at Novo Nordisk, expressed confidence in the potential of once-weekly basal insulin icodec for diabetes patients requiring basal insulin therapy. "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," Lange stated.

The application for insulin icodec was submitted to the FDA in April 2023. In May 2024, the FDA convened an Endocrinologic and Metabolic Drugs Advisory Committee meeting, featuring a panel of independent scientific experts, to evaluate the benefit-risk profile of once-weekly basal insulin icodec for type 1 diabetes. The panel concluded that the available data were insufficient to determine a positive benefit-risk balance for type 1 diabetes. The Advisory Committee did not address the use of once-weekly insulin icodec for type 2 diabetes.

Insulin icodec has been approved under the brand name Awiqli® in various regions, including the EU, Canada, Australia, Japan, and Switzerland, for treating both type 1 and type 2 diabetes. In China, it is approved for the treatment of type 2 diabetes.

Novo Nordisk, founded in 1923 and headquartered in Denmark, is a leading global healthcare company focused on defeating serious chronic diseases. The company pioneers scientific advancements, expands access to its medications, and strives to prevent and ultimately cure diseases. Novo Nordisk employs approximately 66,000 people across 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen under the symbol Novo-B, and its ADRs are listed on the New York Stock Exchange under the symbol NVO.