Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, recommending the marketing authorization for Awiqli® (the branded name for once-weekly basal insulin icodec) for the treatment of diabetes in adults.
The favorable CHMP opinion stems from the findings of the ONWARDS phase 3a clinical trial program. Once-weekly basal insulin icodec exhibited superior blood sugar reduction (measured by HbA1c change) and Time in Range (time spent within the recommended blood sugar range) compared to daily basal insulin in individuals with type 2 diabetes. For individuals with type 2 diabetes who had not previously received insulin treatment, both once-weekly basal insulin icodec and comparators demonstrated clinically significant or severe hypoglycemia rates below one event per patient-year of exposure. In individuals with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycemia compared to insulin degludec. Throughout the program, once-weekly basal insulin icodec appeared to maintain a safe and well-tolerated profile.
Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, stated, “We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli® has the potential to have a significant impact and improve treatment for people living with diabetes. We are committed to driving innovation in diabetes treatment, and Awiqli® has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.”
Final marketing authorization from the European Commission is expected within approximately two months.
Awiqli® is a once-weekly basal insulin analogue intended to cover basal insulin requirements for a full week with a single subcutaneous injection.
The ONWARDS clinical development program consisted of six phase 3a global clinical trials, involving more than 4,000 adults with type 1 or type 2 diabetes, including a trial with real-world elements.
Novo Nordisk, established in 1923 and headquartered in Denmark, is a leading global healthcare company with a focus on defeating serious chronic diseases, particularly diabetes. Operating in 80 countries, Novo Nordisk employs approximately 63,400 individuals and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B), and its ADRs are listed on the New York Stock Exchange (NVO). For further information, visit novonordisk.com or follow visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
