FDA Rejects Novo Nordisk's Weekly Insulin, Requests Information Related To Manufacturing Process, Type 1 Diabetes

On Wednesday, the FDA issued a Complete Response Letter (CRL) related to Novo Nordisk A/S’s NVO Biologics License Application for once-weekly basal insulin icodec for diabetes mellitus.

In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.

Related: Novo Nordisk’s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review.

Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfill the requests.

Novo Nordisk does not expect to be able to fulfill the requests during 2024.

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

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 available data was insufficient to conclude a positive benefit-risk in type 1 diabetes. The Advisory Committee did not discuss using once-weekly insulin icodec in type 2 diabetes.

Insulin icodec is approved under the brand Awiqli in the EU, Canada, Australia, Japan, and Switzerland for type 1 and type 2 diabetes and in China for type 2 diabetes.

Price Action: NVO shares are down 1.46% at $140.65 at the last check on Thursday.

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