Novo Nordisk Resubmits Awiqli® to FDA for Groundbreaking Diabetes Treatment

Novo Nordisk Resubmits Awiqli® to the FDA

Novo Nordisk, a pioneer in diabetes treatment, has made a significant move by resubmitting its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection. This innovative treatment has the potential to become the first once-weekly basal insulin available in the United States for adults diagnosed with type 2 diabetes. If granted approval, Awiqli® could revolutionize the way diabetes is managed, reducing the need for daily insulin injections from 365 to just 52 per year.

Awiqli®: A Game Changer in Diabetes Management

Awiqli® is designed to help individuals who live with type 2 diabetes manage their condition more effectively. According to Anna Windle, PhD, Senior Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, the resubmission emphasizes the company’s commitment to continuing its legacy in improving diabetes care. The goal is to streamline the treatment regimen and enhance the quality of life for patients.

The ONWARDS clinical trial program, which included approximately 4,000 participants, demonstrated promising results comparing the efficacy of Awiqli® to daily basal insulins. Researchers focused on the primary endpoint of change in A1C levels from baseline, a critical indicator of blood sugar control in diabetes management. The findings from this program support the assertion that Awiqli® could significantly benefit those living with type 2 diabetes.

Clinical Trials and Results

The ONWARDS type 2 diabetes phase 3a clinical program comprised five randomized, active-controlled trials. These trials evaluated the effectiveness of Awiqli® against daily basal insulins, providing detailed insights into the potential advantages of a once-weekly treatment. Results showed that Awiqli® could deliver comparable glycemic control while reducing the frequency of injections, making it a compelling alternative for many patients.

This resubmission comes in response to an FDA action letter received in the third quarter of 2024, signaling that Novo Nordisk is focused on addressing the feedback from regulatory authorities to bring this innovative product to market. Awiqli® is already approved in the European Union, where it is also available in 12 additional countries, with plans for regulatory filings in several other nations.

Continuing the Legacy

Novo Nordisk was established in 1923 and has since focused on driving change in the healthcare sector, particularly in the fight against chronic diseases, emphasizing diabetes treatment. With a workforce of approximately 78,400 employees across 80 countries, the company markets its life-changing products in around 170 countries.

For Novo Nordisk, the development and potential approval of Awiqli® signify a step forward in fulfilling their mission to improve the quality of life for those living with diabetes. By continuing to pioneer scientific breakthroughs and focusing on patient needs, the company reinforces its leadership in this critical area of healthcare.

What’s Next?

The submission’s future remains uncertain, with the FDA’s response awaited. If successful, Awiqli® could mark a transformative change in diabetes care in the U.S., potentially impacting the lives of millions of Americans living with type 2 diabetes. The medical community and patients alike look forward to the outcomes of Novo Nordisk’s efforts, hopefully bringing forth a new era in diabetes management.

As Awiqli®– the first of its kind – nears the potential of reaching pharmacy shelves, it illustrates the ongoing innovation in the healthcare field designed to make daily life easier and healthier for individuals managing chronic conditions like diabetes.