Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Novo Nordisk has secured the US Food and Drug Administration (FDA) approval for Awiqli (insulin icodec-abae) injection 700 units/mL, a basal insulin for adults with type 2 diabetes (T2D).
The clinical trials assessed once-weekly Awiqli with mealtime insulin, oral anti-diabetic agents, and GLP-1 receptor agonists. Credit: Andrzej Rostek / Shutterstock.com.
Subscribe to our email newsletter
It is indicated as an adjunct to exercise and diet for improving glycaemic control.
The FDA’s decision is based on data from the ONWARDS Phase IIIa clinical programme, which included four randomised, active-controlled, treat-to-target studies involving nearly 2,680 adults with uncontrolled T2D.
These clinical trials assessed once-weekly Awiqli in combination with a mealtime insulin, oral anti-diabetic agents, and glucagon-like peptide-1 (GLP-1) receptor agonists.
The ONWARDS programme compared Awiqli with daily basal insulin regimens and showed efficacy in the primary endpoint of haemoglobin A1c (HbA1c) levels across all pivotal trials.
The safety profile of Awiqli was generally consistent with that of the daily basal insulin class throughout these trials.
Novo Nordisk president and CEO Mike Doustdar said: “The Awiqli approval reflects Novo Nordisk’s ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes. As the first FDA-approved, once-weekly basal insulin for adults with type two diabetes, it offers an important new treatment option.
“At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment – continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day.”
Novo Nordisk plans to introduce Awiqli using the FlexTouch device in the US market in the second half of 2026.
The product is now approved in 13 additional countries, as well as in the European Union and the US, with market-specific indications for T2D.
Earlier this month, Novo Nordisk received approval from the FDA for a high-dose version of its weight loss drug, Wegovy (semaglutide), as patents protecting the therapy’s market exclusivity approached expiry in certain regions.
