FDA Approves Novo Nordisk’s Insulin Icodec-abae (Awiqli) for T2D

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

On March 26, 2026, the US Food and Drug Administration (FDA) approved Novo Nordisk’s insulin icodec-abae under the name Awiqli for patients with type 2 diabetes (T2D).1,2
In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, highlight the FDA approval of once-weekly insulin icodec, emphasizing its significance as a major advancement in insulin therapy. They begin by addressing practical considerations, including its high concentration (U-700) and the implications for dosing, noting that weekly administration necessitates substantially higher unit doses compared with daily basal insulin.
The discussion focuses on dosing strategy, particularly the need to scale weekly doses approximately sevenfold relative to daily regimens, as well as the rationale for an initial loading dose of 1.5 times the calculated weekly requirement to more rapidly achieve steady state. Isaacs underscores the pharmacokinetic basis for this approach, given the drug’s long half-life and delayed time to steady state, while also noting the constraints of dosing in 10-unit increments.
Bellini and Isaacs explore the clinical implications of once-weekly insulin, with particular attention to adherence and treatment burden. Bellini emphasizes the potential benefit for insulin-naive patients and those struggling with daily injection adherence, framing weekly insulin as a means to significantly reduce injection frequency and improve consistency. Isaacs expands on this, arguing that reduced dosing frequency may mitigate missed doses and glycemic variability, especially in patients with irregular routines. Both highlight the flexibility afforded by the long half-life, allowing for minor deviations in dosing timing without substantial impact on glycemic control.
The conversation also addresses potential risks, including delayed titration and the possibility of over-basalization, particularly in patients with fluctuating nutritional intake or socioeconomic instability. They stress the importance of careful patient selection and monitoring, given the longer interval required to adjust doses.
Reviewing clinical trial data from the ONWARDS phase 3 program, the hosts note that once-weekly insulin demonstrated modestly greater A1C reduction compared with daily basal insulin in treat-to-target trials, reinforcing the hypothesis that improved adherence may translate into better glycemic outcomes.
They further discuss implementation considerations across care settings, highlighting potential advantages for older adults, caregivers, and patients in long-term care, where reduced injection burden may improve safety, independence, and medication management. The episode also touches on current regulatory limitations, noting that while approval is presently limited to type 2 diabetes in the United States, ongoing studies may expand its indication to type 1 diabetes, with off-label use anticipated in select cases.
The hosts conclude by situating weekly insulin within the broader therapeutic landscape, emphasizing renewed innovation in insulin development alongside incretin-based therapies. They note that additional agents in development may soon expand options within this class, signaling a meaningful shift in the management of diabetes toward more patient-centered, lower-burden treatment paradigms.
Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

References
1: Novo Nordisk. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. March 26, 2026. Accessed April 3, 2026. https://ml-eu.globenewswire.com/Resource/Download/cb9dda59-1286-4718-a7e5-4256e2397b0c

2: Kunzmann K. FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes. HCPLive. March 26, 2026. Accessed April 3, 2026. https://www.hcplive.com/view/fda-approves-awiqli-insulin-icodec-first-once-weekly-basal-insulin-for-type-2-diabetes