Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec

Core Viewpoint - Novo Nordisk's Biologics License Application for once-weekly basal insulin icodec has received a Complete Response Letter from the FDA, indicating that further information is required before the application can be reviewed [1][2] Group 1: FDA Response and Application Status - The FDA's Complete Response Letter requests additional information regarding the manufacturing process and the type 1 diabetes indication before the review can be completed [1] - Novo Nordisk does not anticipate fulfilling the FDA's requests during 2024 [1] - The application for insulin icodec was submitted to the FDA in April 2023, and an advisory committee meeting in May 2024 concluded that the available data were insufficient to determine a positive benefit-risk for type 1 diabetes [2] Group 2: Product Approval and Market Presence - Insulin icodec is already approved under the brand name Awiqli® in the EU, Canada, Australia, Japan, and Switzerland for both type 1 and type 2 diabetes, and in China for type 2 diabetes [3] - Novo Nordisk is a leading global healthcare company founded in 1923, employing approximately 66,000 people across 80 countries and marketing products in around 170 countries [3]