Novo Nordisk said that the US Food and Drug Administration has issued a Complete Response Letter or CRL covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus.
In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed.
Novo Nordisk noted that it is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. The company does not expect to be able to fulfil the requests during 2024.
Novo Nordisk submitted the application for insulin icodec to the FDA in April 2023. In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes. The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes. The Advisory Committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.
Insulin icodec is approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for the treatment of type 2 diabetes.
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