On 27 March 2026, Novo Nordisk announced that the FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly, long acting basal insulin for adults with type 2 diabetes.
The US approval follows the issue of a Complete Response Letter (CRL) by the FDA on 10 July 2024 regarding insulin icodec. At the time, the CRL was said to include “requests related to the manufacturing process and the type 1 diabetes indication”.
Awiqli® was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024. It has been approved in Switzerland and Canada (March 2024), Japan and Australia (June 2024) and was endorsed in China in June 2024 for type 2 diabetes.