Novo Nordisk’s weekly insulin for type 1 diabetes faces FDA setback

DENMARK—Novo Nordisk, the Danish drugmaker, has announced that the U.S. Food and Drug Administration (FDA) has declined to approve its weekly insulin for patients with diabetes.

 In their statement, the company mentioned that the FDA issued them a “complete response letter” requesting additional information related to the manufacturing process and the type 1 diabetes indication to complete the review.

According to Novo Nordisk, they submitted the application for insulin icodec to the FDA in April 2023.

Following this, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting took place in May 2024, where a panel of independent scientific experts discussed the benefit-risk profile of once-weekly basal insulin icodec for type 1 diabetes.

However, the panel determined that the available data were insufficient to conclude a positive benefit-risk for type 1 diabetes.

As a result, the panel voted against the use of weekly insulin icodec for patients with type 1 diabetes due to the risks of low blood sugar.

In response to these developments, Novo Nordisk stated that it does not expect to fulfill the FDA’s requests this year.

Nevertheless, they emphasized their commitment to working closely with the FDA to determine the next steps.

Commenting on the situation, Martin Lange, Executive Vice President for Development at Novo Nordisk, expressed his belief in the potential of once-weekly basal insulin icodec for individuals living with diabetes who require basal insulin therapy.

He reiterated the company’s dedication to collaborating with the FDA to identify the necessary steps to complete the review process.

This collaboration aims to make this novel treatment option available to adults living with diabetes as soon as possible.

Insulin icodec is approved under the brand name Awiqli® in several countries, including the EU, Canada, Australia, Japan, and Switzerland, for treating both type 1 and type 2 diabetes.

Additionally, it is approved in China for treating type 2 diabetes.

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