On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus. The CRL is said to include “requests related to the manufacturing process and the type 1 diabetes indication”.
Insulin icodec, under the brand name Awiqli®, was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024. Awiqli® has been approved in Switzerland and Canada (March 2024) and Japan and Australia (June 2024) and was endorsed in China in June 2024 for Type 2 diabetes. Novo Nordisk’s weekly insulin icodec injection is close to approval in India.