Insulin icodec is now available in the US after FDA approval, offering adults with type 2 diabetes a once-weekly basal insulin option.
Novo Nordisk has launched
“Awiqli represents meaningful progress in the options available for basal insulin therapy for the millions of adults with type 2 diabetes,” Tom Scales, senior vice president of market access, public affairs, and patient support solutions at Novo Nordisk, said in the company announcement. The product is expected to be stocked at more than 70,000 US pharmacies, according to Novo Nordisk.
Insulin icodec is administered subcutaneously on the same day each week using a prefilled FlexTouch pen. As a long-acting exogenous insulin, it provides basal insulin activity intended to support glucose control between meals and overnight. Its once-weekly schedule reduces planned basal injections from 7 to 1 per week, although patients may still require mealtime insulin or other glucose-lowering therapies.¹
The FDA decision was supported by the phase 3a ONWARDS program, which compared once-weekly insulin icodec with once-daily basal insulins in adults with type 2 diabetes. The program included randomized, active-controlled, treat-to-target studies conducted in insulin-naive participants, patients previously receiving basal insulin, and patients using basal-bolus therapy. Some trials permitted concomitant oral glucose-lowering agents or glucagon-like peptide-1 receptor agonists.
Across the pivotal type 2 diabetes studies, insulin icodec met the primary end point of noninferiority for change in glycated hemoglobin from baseline to the end of treatment, according to the company. The announcement did not provide trial-specific effect estimates, confidence intervals, or absolute hypoglycemia rates.
Individual ONWARDS trials provide context for the approval. ONWARDS 2 compared switching to weekly insulin icodec with daily insulin degludec among adults whose type 2 diabetes was already treated with basal insulin.² ONWARDS 3 evaluated the same weekly-versus-daily comparison in insulin-naive adults, using a randomized, double-blind design.³ ONWARDS 4 studied insulin icodec against insulin glargine U100 as the basal component of basal-bolus therapy.⁴ These treat-to-target designs establish comparative glycemic efficacy but may not fully reflect adherence, titration, and monitoring in routine practice.
The safety profile was described as generally consistent with that of daily basal insulin comparators. Hypoglycemia remains the principal clinical concern. Other reported risks include severe systemic allergic reactions, hypokalemia, injection-site reactions, lipodystrophy, edema, and weight gain. Heart failure may occur or worsen when insulin is used with a thiazolidinedione.¹
The concentrated weekly formulation also creates practical considerations. Clinicians and patients must select the prescribed dose directly in units without conversion, verify the pen label, and avoid withdrawing insulin with a syringe. Changes in dosing day require at least 4 days between injections, and missed-dose instructions depend on how much time has elapsed.¹ These safeguards may be particularly important because dosing errors could expose patients to a prolonged period of excess insulin activity.
Once-weekly administration could reduce treatment burden for selected adults who find daily injections challenging. However, convenience should not be interpreted as evidence of better long-term adherence, quality of life, or clinical outcomes outside controlled trials. Postmarketing experience will be needed to clarify real-world uptake, medication-error risk, severe hypoglycemia, and outcomes in populations underrepresented in the pivotal program.
