Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application for its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus. This response highlights challenges related to the manufacturing process and concerns specific to the type 1 diabetes indication, delaying the drug’s approval process.

Martin Lange, Executive Vice President for Development at Novo Nordisk, expressed confidence in the potential of insulin icodec, stating, “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.”

The FDA’s requests come after an advisory committee meeting in May 2024, where independent scientific experts convened to assess the benefit-risk profile of insulin icodec for type 1 diabetes. The committee concluded that the available data were insufficient to support a positive benefit-risk assessment for this patient group, though discussions on its use in type 2 diabetes were not covered at this meeting.

Despite the setback in the US, insulin icodec is already approved under the brand name Awiqli® in several other regions, including the EU, Canada, Australia, Japan, Switzerland (for both type 1 and type 2 diabetes), and China (for type 2 diabetes). These approvals highlight the international acceptance and potential benefits of the treatment.

Novo Nordisk remains committed to resolving the FDA’s concerns and has indicated that fulfilling the agency’s latest requests within 2024 might be challenging. This ongoing dialogue with the FDA reflects the complexities and stringent requirements involved in bringing new diabetes treatments to the market, emphasizing the company’s dedication to providing safe and effective new therapies for diabetes management.

As Novo Nordisk navigates through these regulatory hurdles, the diabetes community watches closely, hopeful for a new treatment option that could potentially simplify and improve care management for those requiring basal insulin therapy.

  Biologics License Application, diabetes treatment, FDA, FDA complete response letter, Health Regulatory, insulin icodec, Novo Nordisk