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The FDA on March 26, 2026 approved Novo Nordisk's Awiqli (insulin icodec-abae), the first and only once-weekly basal insulin for adults with type 2 diabetes. The approval marks the first new class of basal insulin to reach US patients in more than two decades, reducing injection burden from 365 to 52 per year.
Insulin icodec is engineered with three amino acid substitutions and a C20 fatty diacid side chain that confers strong, reversible albumin binding. After subcutaneous injection the molecule forms an inactive albumin-bound reservoir, releasing active insulin gradually across the week with a mean half-life of approximately 196 hours.
Approval was supported by the ONWARDS Phase 3a program—five randomised, active-controlled trials enrolling approximately 4,000 adults. In the pivotal ONWARDS 1 trial (984 insulin-naïve patients, 78 weeks), icodec achieved an HbA1c reduction of −1.55 % versus −1.35 % for insulin glargine U100 (ETD: −0.19 %). A significantly higher proportion reached HbA1c <7 % without level 2/3 hypoglycaemia: 52.6 % vs. 42.6 % (p = 0.0028).
The most common adverse events were hypoglycaemia, injection-site reactions, lipodystrophy, pruritus, rash, peripheral oedema and weight gain. Hypoglycaemia rates tended to be modestly higher on days 2–4 of the weekly cycle during the peak-exposure window, though absolute event rates remained below one per patient-year in both arms.
Awiqli is delivered via a FlexTouch prefilled pen (700 units/mL) with a recommended starting dose of 70 units once weekly. Novo Nordisk expects the US commercial launch in the second half of 2026. Approximately 37 million Americans have diabetes, of whom roughly 90–95 % have type 2.
Sources: FDA Novel Drug Approvals 2026; Novo Nordisk.
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