FDA Approves First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available in U.S.

August 11, 2026
FDA Approves First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available in U.S.
  • Aviqli (icodec-abae) is the first once-weekly basal insulin approved in the U.S. for adults with type 2 diabetes, replacing seven daily injections with a single weekly dose via a prefilled FlexTouch pen.

  • Awiqli® is administered once weekly on the same day each week using the FlexTouch pen, with emphasis on correct device use, site rotation, and safety to prevent dosing errors.

  • The press release provides safety information, contraindications, and reminders to consult healthcare providers for dosing and managing hypoglycemia.

  • Future steps include post-marketing safety studies in Japan, ongoing type 1 diabetes trials, and potential label changes as new safety data emerge.

  • Pricing and access: list price is $99 per package, with affordability programs potentially lowering patient costs to about $35 monthly for insured and $55 monthly for uninsured, depending on formulary coverage.

  • European regulators required educational materials to prevent dosing errors given potential confusion with similar pens.

  • Novo Nordisk provides Patient Education Center via NovoCare.com offering patient resources and affordability support, plus prescribing information and safety guidelines available at Awiqli.com and in NovoCare resources.

  • The product is approved only for adults with type 2 diabetes and not for type 1 diabetes or children.

  • Awiqli is available outside the United States, including the European Union, Canada, Australia, and Japan.

  • Prescribing information warns against syringe withdrawal, dialing the maximum dose unless prescribed, and mixing with other insulins due to severe overdose risk.

  • Real-world data and pricing/coverage considerations may affect out-of-pocket costs; a competing weekly insulin (efsitora alfa) could influence future options and pricing.

  • Dosing transition from daily basal to weekly requires converting the total weekly dose and not self-switching; missed or late doses require monitoring due to longer drug persistence.

Summary based on 5 sources


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