Novo Nordisk's Awiqli approved by FDA as first once-weekly basal insulin for children 10+ with type 2 diabetes
- FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL as a once-weekly basal insulin for children 10 years and older with type 2 diabetes.
- Awiqli reduces basal injection frequency from seven per week to one.
- Approval is supported by adult ONWARDS trials and a single-dose pediatric pharmacokinetic study in patients aged 10 to <18.
- Common adverse effects include hypoglycemia, serious allergic reactions, injection-site reactions, lipodystrophy, itching or rash, swelling, and weight gain.
Regulatory approval and indication
The FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL as the first once-weekly long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in children 10 years of age and older with type 2 diabetes. Awiqli is administered once weekly on the same day each week using the Awiqli FlexTouch pen.
Clinical evidence
The approval is supported by adequate and well-controlled adult studies from the ONWARDS program and a single-dose pharmacokinetic study in pediatric patients aged 10 to <18 that evaluated once-weekly pharmacokinetics. The ONWARDS program evaluated efficacy and safety across insulin‑naive and insulin‑treated adult type 2 diabetes populations.
Safety and administration
Awiqli is a U‑700 long‑acting insulin designed as an alternative to daily basal insulin; it reduces weekly basal injections from seven to one. Reported common adverse reactions include hypoglycemia, serious allergic reactions, injection‑site reactions, skin changes at injection sites (lipodystrophy), itching, rash, peripheral swelling, and weight gain.
Availability
Awiqli is available at more than 70,000 pharmacies and is approved in the US, the EU, and 18 additional countries, with market-specific indications for diabetes.
Source: Novo Nordisk