Once‑weekly insulin approved
The FDA approved Novo Nordisk’s once‑weekly basal insulin Awiqli (icodec) for adults with type 2 diabetes, introducing a new convenience‑driven insulin class. Weekly dosing could materially change adherence dynamics and long‑term outcome projections in diabetes analytics. (pharmaceutical-business-review.com, pharmexec.com)
Awiqli is formulated as insulin icodec‑abae at 700 units/mL and will be supplied in Novo Nordisk’s FlexTouch prefilled pen. (novonordisk.mediaroom.com (novonordisk.mediaroom.com)) The pivotal ONWARDS development programme included six phase 3a global trials covering both type 1 and type 2 diabetes (more than 4,000 adults), while the FDA filing relied on four randomized, active‑controlled, treat‑to‑target T2D trials enrolling approximately 2,680 adults. (novonordisk.com (novonordisk.com); novonordisk.mediaroom.com (novonordisk.mediaroom.com)) In the randomized ONWARDS 3 trial of insulin‑naïve adults with T2D, mean HbA1c fell an estimated 1.6 percentage points with once‑weekly icodec versus 1.4 points with once‑daily degludec at 26 weeks (estimated treatment difference −0.2 percentage points, 95% CI −0.3 to −0.1; noninferiority and confirmed statistical superiority). (jamanetwork.com (jamanetwork.com)) Across ONWARDS trial reports, more insulin‑naïve participants achieved HbA1c <7.0% without experiencing clinically significant or severe hypoglycaemia in the icodec arms versus daily basal comparators, and ONWARDS‑1 reported superior Time‑in‑Range for once‑weekly icodec versus daily basal insulin. (prnewswire.com (prnewswire.com)) Novo’s prescribing information flags hypoglycemia as the most commonly observed adverse reaction and includes boxed warnings on medication errors and accidental overdose (explicitly instructing patients not to transfer Awiqli from the FlexTouch pen into a syringe because doing so can cause severe overdosage). (novo-pi.com (novo-pi.com)) Novo Nordisk plans a US nationwide launch of Awiqli in the second half of 2026, with the product already authorised in the EU and 13 additional countries; regulatory filings and FDA review materials show overall icodec safety was evaluated across thousands of participants with a total exposure measured in ~2,119 patient‑years in the ONWARDS programme. (novonordisk.mediaroom.com (novonordisk.mediaroom.com); fda.gov (fda.gov))
