Novo Nordisk announced that the FDA issued a Complete Response Letter (CRL) related to its once-weekly insulin submission.
In the CRL, the FDA made requests for Novo Nordisk to complete before it can complete its review of a Biologics License Application (BLA). As a result, the insulin maker said it does not expect to fulfill the requests by the end of 2024. The company plans to work closely with the FDA to fulfill the requests over time, however.
Novo Nordisk submitted its once-weekly basal insulin icodec for treating diabetes mellitus to the FDA in April 2023. In May of this year, an FDA advisory meeting convened to discuss the benefits and risks of the once-weekly insulin for type 1 diabetes. The panel deemed the available data insufficient to conclude on a positive benefit-risk profile. It did not discuss the use of the once-weekly insulin for type 2 diabetes.
At last year’s 83rd Annual Scientific Sessions of the American Diabetes Association (ADA), Novo Nordisk shared positive data, highlighting that its once-weekly insulin met primary endpoints in the ONWARDS 1 study. The company currently offers the insulin under the brand name Awiqli in Europe, Canada, Australia, Japan and Switzerland. In those geographies, it treats both type 1 and type 2 diabetes, while the company also offers it for type 2 in China.
‘We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, EVP for development at Novo Nordisk. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes’’.
