Once‑weekly insulin approved
The FDA approved Novo Nordisk’s once‑weekly basal insulin Awiqli for type‑2 diabetes, a convenience innovation that could improve adherence and alter consumer health behavior patterns. (reuters.com (tipranks.com))
Awiqli’s active ingredient is insulin icodec‑abae delivered as a 700 units/mL solution in a FlexTouch® pre‑filled pen, and Novo Nordisk says it expects a U.S. launch in the second half of 2026. (novonordisk.ca) The FDA decision was supported by the ONWARDS phase 3a programme—four randomized, active‑controlled, treat‑to‑target trials enrolling roughly 2,680 adults with uncontrolled type 2 diabetes that demonstrated A1C reductions versus daily basal insulin. (prnewswire.com) Regulatory labeling specifies a recommended weekly starting dose of 70 units for insulin‑naïve adults with individual once‑weekly titration, and the pen allows dosing from 10 to 700 units in 10‑unit increments. (ema.europa.eu) Awiqli is a U‑700 formulation and the product information states one unit of insulin icodec corresponds to one unit of insulin glargine, detemir, degludec or one international unit of human insulin—requiring explicit unit‑for‑unit conversion when switching regimens. (ema.europa.eu) Labelled common and serious adverse events include hypoglycaemia, severe allergic reactions, injection‑site reactions, lipodystrophy, peripheral oedema and weight gain, and regulators caution that combining icodec with pioglitazone or other TZDs may worsen or precipitate congestive heart failure. (prnewswire.com) Novo Nordisk noted Awiqli is already approved in the EU and 13 additional countries and CEO Mike Doustdar said the approval “reaffirms the company’s commitment” to investment in insulin innovation, access and supply. (markets.ft.com)
