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FDA Approval Advances Basal Insulin

Weekly dosing reduces injection frequency vs daily regimens, with phase 3 data supporting efficacy and class-consistent safety.

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The FDA has approved insulin icodec-abae (Awiqli) as the first once-weekly basal insulin for improving glycemic control in adults with type 2 diabetes. This innovative treatment shifts from seven injections to just one per week, using the Awiqli FlexTouch device. The approval follows the ONWARDS phase 3a program, which demonstrated effective HbA1c reduction in around 2,680 adults with uncontrolled type 2 diabetes. With a consistent safety profile compared to daily options, Awiqli is set for a US launch in late 2026, following approvals in the EU and 13 other countries.

Original Source(s)

FDA Approval Advances Basal Insulin

  • by Kathryn Wighton

  • March 27, 2026

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