Novo Nordisk Receives Critical FDA Response On Weekly Insulin Icodec

Novo Nordisk received a Complete Response Letter (CRL) from the FDA concerning their Biologics License Application for once-weekly basal insulin icodec, intended for diabetes mellitus treatment. The FDA's letter outlines specific requests regarding the manufacturing process and the inclusion of type 1 diabetes as an indication. Novo Nordisk is currently reviewing the CRL's contents and plans to collaborate closely with the FDA to address these requests. They anticipate that fulfilling these requirements may extend beyond 2024.

Martin Lange, executive vice president for Development at Novo Nordisk said, “We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require 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’’.

In April 2023, Novo Nordisk submitted its application for insulin icodec to the FDA. In May 2024, the FDA convened an Endocrinologic and Metabolic Drugs Advisory Committee meeting, where independent scientific experts assessed the benefit-risk profile of once-weekly basal insulin icodec specifically for type 1 diabetes. The panel concluded that the available data did not provide sufficient evidence to support a positive benefit-risk assessment for type 1 diabetes. Notably, the Advisory Committee did not address the use of once-weekly insulin icodec in type 2 diabetes. Outside the United States, insulin icodec is approved under the brand name Awiqli® for treating both type 1 and type 2 diabetes in the EU, Canada, Australia, Japan, and Switzerland. In China, it is approved specifically for treating type 2 diabetes.