Novo Nordisk A/S, a leading global healthcare company, announced on July 10, 2024, that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application of its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. The FDA's CRL highlighted requests concerning the manufacturing process and the type 1 diabetes indication, which must be addressed before the application review can be finalized. Novo Nordisk, which submitted the application in April 2023, has stated it does not anticipate meeting the FDA's requests within 2024. The company had previously faced a setback in May 2024 when an FDA Advisory Committee found insufficient data to establish a positive benefit-risk assessment for type 1 diabetes, without...Show More

Novo Nordisk A/S, a leading global healthcare company, announced on July 10, 2024, that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application of its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. The FDA's CRL highlighted requests concerning the manufacturing process and the type 1 diabetes indication, which must be addressed before the application review can be finalized. Novo Nordisk, which submitted the application in April 2023, has stated it does not anticipate meeting the FDA's requests within 2024. The company had previously faced a setback in May 2024 when an FDA Advisory Committee found insufficient data to establish a positive benefit-risk assessment for type 1 diabetes, without discussing type 2 diabetes. Despite these challenges, Novo Nordisk remains committed to working with the FDA to provide this new treatment option to adults with diabetes. Insulin icodec is already approved in the EU, Canada, Australia, Japan, Switzerland, and China under the brand name Awiqli® for both type 1 and type 2 diabetes, except in China where it is approved only for type 2 diabetes.