The U.S. Food and Drug Administration (FDA) has approved Awiqli, a new long-acting insulin injection that only needs to be administered once a week. This marks a significant shift for people with type 2 diabetes who currently rely on daily injections to manage their blood sugar. The approval addresses a long-standing need for a more convenient insulin regimen, potentially improving adherence and quality of life for millions.
A Major Change in Diabetes Management
Over 37 million Americans live with diabetes, and more than 8 million of them use insulin. Existing treatments often require daily injections, which can be disruptive and inconvenient. Awiqli, manufactured by Novo Nordisk, aims to simplify this process by allowing patients to take their basal insulin dose just once weekly using a prefilled disposable pen.
Clinical trials, involving nearly 3,000 adults with uncontrolled type 2 diabetes, showed Awiqli was as effective as daily insulin injections in controlling blood sugar levels (as measured by A1C tests). Researchers found no significant safety differences between the two regimens, with similar potential side effects:
- Hypoglycemia (low blood sugar)
- Allergic reactions
- Injection site reactions
- Skin changes
- Weight gain
Not Yet for All Diabetics
The FDA has not approved Awiqli for children or people with type 1 diabetes. While it is approved for type 1 diabetes in some other countries (like Canada), the FDA determined that it posed a higher risk of low blood sugar in this population.
Why This Matters
Experts say the weekly injection format could encourage better treatment adherence. Many people hesitate to switch from oral medications to daily insulin, but a weekly injection may feel less burdensome.
“Patients would likely be more willing to add in another weekly injection, allowing us to intensify therapy more quickly,” says clinical pharmacist John Aurora.
The convenience factor could also improve quality of life for people already using weekly GLP-1 injections for diabetes management.
Competition on the Horizon
Novo Nordisk is not alone in developing once-weekly insulin. Eli Lilly has a competing product, efsitora, currently in phase 3 trials. The company plans to submit it to U.S. regulators by the end of 2025, potentially bringing another option to patients soon.
Awiqli is expected to be available nationally in the coming months. The FDA approval marks a step toward easier and more manageable diabetes care, though careful patient education and awareness of potential side effects will be crucial.
