FDA Approves Once-Weekly Basal Insulin Awiqli for Type 2 Diabetes

Awiqli, the first once-weekly basal insulin approved by the FDA, was tested in nearly 2,680 adults with uncontrolled type 2 diabetes.

Awiqli® has become the first and only once-weekly long-acting basal insulin approved by the United States Food and Drug Administration for adults living with type 2 diabetes, offering a new option for improving blood sugar control alongside diet and exercise (1^✔ ✔Trusted Source
Awiqli

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Novo Nordisk announced that the US FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes.

The approval introduces the only once-weekly basal insulin option currently available, emphasizing the growing importance of personalized diabetes care and treatments that suit different patient routines and preferences.

Weekly Insulin Option Reduces Daily Injection Burden

Anna Windle, Ph.D., Group Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk Inc., described Awiqli as an important advancement for adults with type 2 diabetes.

She explained that the once-weekly insulin could help address difficulties linked with daily basal insulin injections by reducing injection frequency from seven times a week to just once weekly. According to her, the treatment provides an alternative option for adults who may benefit from a more manageable insulin routine.

Awiqli Evaluated Alongside Mealtime Insulin and Oral Drugs

The approval was supported by findings from the ONWARDS type 2 diabetes phase 3a clinical program for once-weekly Awiqli injections.

• The program included four randomized, active-controlled, treat-to-target trials involving nearly 2,680 adults with uncontrolled type 2 diabetes.
• Participants used Awiqli either alongside mealtime insulin or in combination with common oral anti-diabetic medications and/or glucagon-like peptide-1 receptor agonists.
• The ONWARDS clinical program compared once-weekly Awiqli with daily basal insulin and demonstrated effectiveness in reducing A1C levels across the pivotal clinical trial program for adults with type 2 diabetes.
• Across the trials, the safety profile of Awiqli remained generally consistent with the daily basal insulin class.

Common adverse events included hypoglycemia, severe allergic reactions, injection site reactions, lipodystrophy, itching, rash, swelling in the hands and feet, and weight gain (2^✔ ✔Trusted Source
Awiqli: FDA Approves First and Only Once-Weekly Long-Acting Basal Insulin for Adults With Type 2 Diabetes

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).

Improving Insulin Adherence in Type 2 Diabetes

Julio Rosenstock, M.D., Principal Investigator for the ONWARDS trial program and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, noted that the introduction of daily long-acting basal insulin injections more than two decades ago significantly improved treatment for adults with type 2 diabetes who required basal insulin therapy. However, he added that many adults still struggle to begin and continue daily insulin treatment.

He emphasized the need for alternative insulin options that may help patients and health care providers choose treatments that best match individual needs. According to Rosenstock, evidence suggests that weekly injectable diabetes medications may improve patient adherence.

He stated that a weekly basal insulin option such as insulin icodec-abae could transform insulin management for adults with type 2 diabetes by offering a treatment routine that feels easier to maintain while helping patients work toward blood sugar goals.

In conclusion, the approval of Awiqli introduces a new once-weekly insulin option for adults with type 2 diabetes, potentially making insulin management more convenient while supporting blood sugar control and improving treatment adherence.

References:

1. Awiqli – (https://www.novo-pi.com/awiqli.pdf)
2. Awiqli: FDA Approves First and Only Once-Weekly Long-Acting Basal Insulin for Adults With Type 2 Diabetes – (https://www.webmd.com/drugs/updates/awiqli-once-weekly-long-acting-basal-insulin-for-adults-with-type-2-diabetes)

Source-Medindia