Launches·October 23, 2026 at 2:03 PM EDT·2 sources
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
Estimated people age ≤19 with type 2 diabetes by 2050Nearly 84,000
Pharmacies where Awiqli is availableMore than 70,000
Minimum approved age10 years
What happened
- The FDA approved Novo Nordisk’s Awiqli as the first once-weekly basal insulin for children 10 years and older with type 2 diabetes.
- Awiqli reduces basal insulin injections from seven per week to one, and is used alongside diet and exercise to improve glycemic control.
- The approval is supported by adult efficacy and safety studies plus a single-dose pharmacokinetic study in pediatric patients ages 10 to <18.
Minimum approved age
10 years
Weekly basal injections
Seven to one per week
Estimated people age ≤19 with type 2 diabetes by 2050
Nearly 84,000
Pharmacies where Awiqli is available
More than 70,000
Why it matters
The approval expands pediatric type 2 diabetes treatment options and may reduce adherence barriers associated with daily insulin injections. It is relevant to healthcare professionals monitoring pediatric diabetes care, treatment access and pharmaceutical product adoption.
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Timeline
- First reported by U.S. FDAOct 23FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
- PR Newswire reportsOct 23Novo's Awiqli® receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes
Who is involved
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Me…Novo NordiskU.S. Food and Drug AdministrationAwiqliMichael Radin
CompanyAgencyPerson
Sources (2)
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