FDA Approval Advances Basal Insulin - Takeaways - MDSpire

FDA Approval Advances Basal Insulin

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

  • By

  • Kathryn Wighton

  • March 27, 2026

  • 2 min

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  • 1

    The FDA approved insulin icodec-abae (Awiqli) as the first once-weekly basal insulin for adults with type 2 diabetes.

  • 2

    Insulin icodec-abae reduces weekly injections from seven to one, administered using the Awiqli FlexTouch device.

  • 3

    The approval was based on the ONWARDS phase 3a program involving 2,680 adults with uncontrolled type 2 diabetes.

  • 4

    The clinical trials demonstrated efficacy in reducing HbA1c levels compared to daily basal insulin.

  • 5

    Awiqli is expected to launch in the US in the second half of 2026, with varying indications in different markets.

Original Source(s)

FDA Approval Advances Basal Insulin

  • by Kathryn Wighton

  • March 27, 2026

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