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Novo Nordisk Resubmits Biologics License Application to FDA for Awiqli
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Key Takeaways
- Novo Nordisk's resubmission for Awiqli is based on the ONWARDS Phase IIIa program, involving over 4,000 adults with type 2 diabetes.
- Awiqli aims to reduce basal insulin injections from 365 to 52 annually, offering a significant improvement for type 2 diabetes management.
Novo Nordisk aims to revolutionize diabetes care with Awiqli, a potential once-weekly insulin, resubmitted for FDA approval after addressing previous concerns.
Awiqli holds the potential to be the first once-weekly basal insulin treatment for type 2 diabetes in adults.
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Novo Nordisk announced its resubmission of its Biologics License Application (BLA) to FDA for Awiqli. If Awiqli receives approval, it would become the first once-weekly basal insulin available in the U.S., while offering an alternative to daily basal insulin injections for adults suffering from type 2 diabetes.
Why did Novo Nordisk resubmit it’s BLA for Awigli for approval?
Novo Nordisk based its resubmission on results from the ONWARDS type 2 diabetes Phase IIIa program for once-weekly Awiqli which is comprised of five randomized, active-controlled, treat-to-target clinical trials in upwards of 4,000 adults with type 2 diabetes. The clinical program compared Awiqli against daily basal insulin, with the primary endpoint of the trials being a change in A1C from baseline.1
"With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," said Anna Windle, PhD, senior vice president, clinical development, medical and regulatory affairs at Novo Nordisk. "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that Awiqli can help streamline the basal insulin injection regimen for people living with type 2 diabetes."
When did Novo Nordisk submit its first BLA for Awigli?
Novo Nordisk initiated its pursuit for approval of Awigli back in April 2023, submitting its BLA to FDA along with sending it to regulatory officials in the EU and China.2 Novo Nordisk’s BLA included data assembled from the Phase III ONWARDS clinical development program comprised of six trials comprised of 4000 adults with type 1 diabetes (T1D). An FDA Endocrinologic and Metabolic Drugs advisory committee meeting back in May 2024, resulted in FDA’s decision that the available data was insufficient and unable to support a positive benefit-risk ratio of insulin icodec in T1D, according to a report from Patient Care, the vote by the panel of independent experts was 7-to-4 against recommending approval.2
FDA issued a Complete Response Letter (CRL) to Novo Nordisk back in July 2024, requesting additional data on the manufacturing process used to produce Awigli, along with its specific indication for T1D. 2 Novo Nordisk’s recent resubmission of Awigli is in response to this CRL.
Martin Lange, executive vice president for development at Novo Nordisk, touched on the CRL in a statement last year, saying, “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.’’
Sources
- Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes Novo Nordisk September 29, 2025 https://www.prnewswire.com/news-releases/novo-nordisk-resubmits-awiqli-to-the-fda-with-potential-to-be-the-first-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302570057.html
- FDA Issues CRL to Novo Nordisk for Once-Weekly Insulin Icodec Patient Care July 11, 2024 https://www.patientcareonline.com/view/fda-issues-crl-to-novo-nordisk-for-once-weekly-insulin-icodec
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