In a significant development for the diabetes community, particularly those living with type 2 diabetes, Novo Nordisk's Awiqli® (once-weekly basal insulin icodec) has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This recommendation marks a pivotal moment in diabetes care, offering a new and potentially transformative approach to managing this chronic condition.
Transforming Diabetes Treatment with Awiqli®
Awiqli® is not just another insulin product; it represents a leap forward in diabetes management. Designed to cover basal insulin requirements for a full week with a single subcutaneous injection, Awiqli® aims to simplify the lives of those living with diabetes. The ONWARDS phase 3a clinical trial program, which served as the basis for CHMP's positive opinion, demonstrated that Awiqli® achieved superior blood sugar reduction and Time in Range compared to daily basal insulin in people with type 2 diabetes. This is particularly noteworthy for individuals who have not previously been treated with insulin, where the overall observed rates of clinically significant or severe hypoglycemia were below one event per patient-year of exposure with both Awiqli® and comparators.
A Significant Impact on Treatment Adherence
One of the most promising aspects of Awiqli® is its potential to improve treatment adherence. The convenience of a once-weekly injection cannot be overstated, especially when compared to the daily injections required by traditional basal insulins such as insulin glargine U100. In clinical trials, patients taking Awiqli® weekly demonstrated better glycemic control and adherence to treatment than those on daily injections. This improvement in adherence is crucial, as it directly correlates with better long-term health outcomes for individuals with diabetes.
Looking Ahead: FDA Approval and What It Means for the US
While Awiqli® is on the cusp of receiving marketing authorization in Europe, anticipation is building for its approval in the United States. Expected later this year, FDA approval of Awiqli® would be a boon for the millions of Americans living with type 2 diabetes, particularly those who are currently managing their condition with basal insulin. The introduction of Awiqli® into the US market could significantly ease the daily burden of diabetes management, offering a more flexible and less intrusive treatment option.
Summary
The recommendation for approval of Awiqli® by European regulatory authorities is great news for the diabetes community. It underscores the ongoing innovation in diabetes treatment and the commitment to improving the quality of life for those affected by this chronic disease. As we await FDA approval in the United States, the potential impact of Awiqli® on diabetes care is immense, promising a new era of convenience, adherence, and control for people living with diabetes.
Frequently Asked Questions
How does once-weekly basal insulin icodec compare in cost to daily basal insulins currently on the market?
Novo Nordisk may offer patient assistance programs to help manage costs, and the final pricing will likely be influenced by various factors including insurance coverage and regional pricing strategies.
Can once-weekly basal insulin icodec be used in conjunction with oral diabetes medications or other injectable therapies?
While the press release does not explicitly address the compatibility of once-weekly basal insulin icodec with other diabetes medications, it is common for basal insulins to be used alongside oral diabetes medications or other injectable therapies as part of a comprehensive diabetes management plan. Patients should consult with their healthcare provider for personalized advice.
What are the potential side effects of once-weekly basal insulin icodec, and how do they compare to those of daily basal insulins?
Once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile across the ONWARDS clinical trial program. In people with type 2 diabetes, the overall observed rates of clinically significant or severe hypoglycemia were below one event per patient-year of exposure, similar to comparators. In people with type 1 diabetes, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycemia compared with insulin degludec. This suggests that while the side effect profile is generally favorable, there may be differences in the risk of hypoglycemia compared to some daily basal insulins.
