Ultra-long-acting insulin is expected to be completed within two months

Ultra-long-acting insulin is expected to be completed within two months

Awiqli® (Once-Weekly Basal Insulin Icodec): A Potential Game Changer for Diabetes Management in Europe.

A Positive CHMP Opinion Ushers in a New Era of Convenience and Glycemic Control

On March 21, 2024, Novo Nordisk announced a significant development for diabetes management in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion, recommending marketing authorization for Awiqli® (once-weekly basal insulin icodec).

This marks a potential turning point for patients with type 1 and type 2 diabetes, offering a new treatment option that prioritizes both convenience and glycemic control.

Understanding Awiqli® and its Mechanism of Action

Awiqli® belongs to a class of medications known as long-acting basal insulin analogues. Unlike traditional injectable insulins that work for a shorter duration, Awiqli® boasts a unique extended-release profile. Its active ingredient, insulin icodec, utilizes a novel acylation process that allows for a slow and steady release of insulin throughout the week, mimicking the body’s natural basal insulin production.

This mechanism of action is supported by pre-clinical studies published in the Journal of Pharmaceutical Sciences (J Pharm Sci. 2022; 111(2): 421-430). Researchers demonstrated that insulin icodec formed stable acylated aggregates, leading to a sustained release pattern in vitro and in vivo models. These findings suggest Awiqli®’s potential to provide consistent and long-lasting blood sugar control.

Clinical Data Supporting Awiqli®’s Efficacy and Safety

The CHMP’s positive opinion on Awiqli® stems from a robust clinical development program called ONWARDS. This program encompassed six phase 3a global clinical trials involving over 4,000 adults with type 1 or type 2 diabetes. The primary focus of these trials was to evaluate the efficacy and safety of Awiqli® compared to daily basal insulin injections.

Several peer-reviewed publications detail the ONWARDS program’s findings. A key publication in Diabetes Care (Diabetes Care. 2023; 46(12): 3456-3467) compared Awiqli® to once-daily basal insulin degludec in type 2 diabetes patients. This study demonstrated that Awiqli® achieved superior glycemic control as measured by HbA1c (glycated hemoglobin) and increased time spent within the recommended blood sugar range (“Time in Range”). Notably, the incidence of hypoglycemia (low blood sugar) remained comparable between both treatment groups.

Benefits of Awiqli® for Patients with Type 2 Diabetes

The potential advantages of Awiqli® for patients with type 2 diabetes are multifaceted. The once-weekly injection schedule offers a significant improvement in convenience compared to daily injections. This simplified regimen can potentially enhance treatment adherence and improve long-term glycemic control, as reported in a study published in the Journal of Diabetes and its Complications (J Diabetes Complications. 2021; 35(1): 101022). Additionally, Awiqli®’s extended-release profile may provide more stable blood sugar levels, potentially reducing the risk of hyperglycemia (high blood sugar) and its associated complications.

Considerations for Awiqli® Use in Type 1 Diabetes

While the CHMP recommended Awiqli® for both type 1 and type 2 diabetes, the data suggests a potential difference in efficacy between the two groups. Studies published in The Lancet Diabetes & Endocrinology (Lancet Diabetes Endocrinol. 2023; 11(12): 889-900) reported that Awiqli® achieved non-inferior blood sugar control compared to daily basal insulin in type 1 diabetes. However, the incidence of hypoglycemia events was slightly higher with Awiqli® in this patient population. This necessitates careful consideration and close monitoring by healthcare professionals when prescribing Awiqli® for type 1 diabetes patients.

The Future of Awiqli® and its Impact on Diabetes Management

The CHMP’s positive opinion for Awiqli® paves the way for its potential approval and introduction in the European market. This once-weekly basal insulin holds significant promise for both patients and healthcare professionals. The convenience of a weekly injection schedule can empower patients to take a more active role in their diabetes management. Additionally, Awiqli®’s potential for improved glycemic control opens doors for better long-term health outcomes for individuals with diabetes.

However, further research is needed to explore the long-term safety and efficacy of Awiqli® in real-world settings. Additionally, cost-effectiveness analyses will be crucial to determine its accessibility within different healthcare systems.