US Edition
FDA Approves First Weekly Insulin Shot for Type 2 Diabetes
Novo Nordisk’s insulin icodec offers a once-weekly alternative to daily injections for type 2 diabetes, improving adherence in 2,680 adults in the ONWARDS trials.
- On Friday, the FDA approved insulin icodec as the first once-weekly basal insulin for glycemic control in adults with Type 2 diabetes as an adjunct to diet and exercise.
- Designed to reduce treatment burden, the once-weekly injection aims to improve patient compliance compared to daily basal insulin by helping transport blood sugar into cells.
- The phase IIIa ONWARDS program enrolled roughly 2,680 adults, showing insulin icodec achieved greater average HbA1c reduction than once-daily insulin glargine U100 over 52 weeks with an estimated difference of-0.19%.
- Safety concerns previously led the FDA to reject insulin icodec for Type 1 diabetes in 2024, citing manufacturing issues and higher risk of severe hypoglycemia.
- Novo Nordisk expects to launch once-weekly insulin icodec in the second half of this year, with patients administering doses on the same day each week using a pre-filled FlexTouch device.
52 Articles
52 Articles
First Once-Weekly Basal Insulin Approved for Type 2 Diabetes
(MedPage Today) -- The FDA approved insulin icodec (Awiqli) as the first once-weekly, long-acting basal insulin for glycemic control in adults with type 2 diabetes, developer Novo Nordisk announced. Of note, the agency rejected the product in...
InsideNoVA.com
FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes
Awiqli® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA1Awiqli® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing these injections from seven to one per week1The Awiqli® approval reflects Novo…
Novo Nordisk A/S: Awiqli® approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes
Awiqli® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDAAwiqli® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing these injections from seven to one per weekNovo Nordisk expects to launch Awiqli® nationwide in the US in the second half of 2026.Bagsværd, Denmark, 27 March 2026 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has…
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