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Insulin Icodec Receives FDA Complete Response Letter, Additional Data Required for Approval

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Insulin icodec a once-weekly basal insulin intended for the treatment of diabetes mellitus, has received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) regarding Novo Nordisk’s Biologics License Application (BLA). The CRL indicates that the FDA requires additional information concerning the treatment’s manufacturing process and its indication for type 1 diabetes before completing its review.

“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, EVP, Development, Novo Nordisk, in a press release. “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.”

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Novo Nordisk initially submitted the BLA to the FDA for insulin icodec in April 2023. In May, an FDA Advisory Committee evaluated the benefit-risk profile of insulin icodec in patients with type 1 diabetes but concluded that the data was insufficient for a positive recommendation. The committee did not review the use of insulin icodec for type 2 diabetes.

Insulin Icodec Shows Impressive Results in ONWARDS Clinical Trials

The treatment is currently approved under the name Awiqli in several countries, including the EU, Canada, Australia, Japan, and Switzerland, for the treatment of both type 1 and type 2 diabetes. In China, it is approved for the treatment of type 2 diabetes. These approvals were based on the results from the ONWARDS clinical development program, which included six Phase IIIa clinical trials investigating the efficacy and safety of once-weekly insulin icodec. Over 4,000 patients with type 1 or type 2 diabetes participated in these trials, which incorporated real-world elements.

In the ONWARDS clinical trials, insulin icodec consistently demonstrated impressive results in reducing the estimated mean HbA1c from baseline. At week 52, ONWARDS 1 showed that insulin icodec was both non-inferior and superior to insulin glargine U100. Similarly, ONWARDS 2 and ONWARDS 3, at week 26, found insulin icodec to be non-inferior and superior to insulin degludec. ONWARDS 4, at week 26, confirmed non-inferiority versus insulin glargine U100. In ONWARDS 5, at week 52, insulin icodec, when used with a dosing guide app, demonstrated non-inferiority and superiority over basal insulin analogs. Lastly, ONWARDS 6, at week 26, indicated non-inferiority compared to insulin degludec.

In June 2023, Novo Nordisk presented data from the ONWARDS 1 and ONWARDS 3 trials at the 83rd Annual Scientific Sessions of the American Diabetes Association. These presentations highlighted the significant improvements in glycemic control achieved with insulin icodec.

Insulin Icodec

Insulin Icodec Shows Promise in Enhancing Glycemic Control and Patient Adherence

“Time in Range provides additional information to help us assess glycaemic control and is an increasingly important tool to complement HbA1c measurements, which were substantially reduced by once-weekly basal insulin icodec. In ONWARDS 1, insulin icodec allowed people to spend significantly more Time in Range, with comparable Time below Range vs once-daily basal insulin glargine U100,” said Julio Rosenstock, MD, lead trial investigator, director of Velocity Clinical Research at Medical City Dallas, and clinical professor of Medicine at the University of Texas Southwestern Medical Center. “A once-weekly basal insulin has the potential to change how we treat people with type 2 diabetes needing basal insulin replacement.”

While Novo Nordisk is currently reviewing the requests made in the CRL, the company has stated that it does not expect to complete the process by the end of the year. The company remains committed to working with the FDA to address the agency’s concerns and bring this innovative treatment option to patients with diabetes.

Insulin icodec represents a significant advancement in diabetes care, offering the potential for improved patient adherence and glycemic control with its once-weekly dosing regimen. As Novo Nordisk continues to engage with the FDA, the diabetes community eagerly awaits the potential approval of this novel therapy.

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Resource: Novo Nordisk, July 11, 2024


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