Novo Nordisk has announced that the FDA responded to its application for the approval of insulin icodec, a once-weekly formulation of basal insulin, as treatment for diabetes.
In its response, the FDA has issued a series of requests related to the manufacturing process and the type 1 diabetes indication, which will have to be fulfilled before the application review can be completed. Novo Nordisk has stated that it will be working closely with the FDA to fulfill the requests, but it does not expect to be able to do so during 2024.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, Executive Vice President 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.’’
Insulin is the standard treatment to manage blood sugar levels in people with diabetes, both type 1 and 2. Basal insulin is designed to keep certain levels of insulin in the bloodstream during the day and is typically injected once a day as compared to bolus insulin, which is injected before each meal. Insulin icodec is the world’s first weekly basal insulin, offering patients a more convenient option compared to daily injections.
Novel treatment for diabetes
Novo Nordisk submitted an application with the FDA for the approval of insulin icodec in April 2023. In May this year, a panel of independent scientists determined that the data provided by Novo was not enough to establish a positive benefit-risk ratio in the treatment of type 1 diabetes.
Insulin icodec received EMA approval in June this year for the treatment of both type 1 and type 2 diabetes. The drug has also been approved in Canada, Australia, Japan and Switzerland for both indications, and in China only for type 2 diabetes.
The approval of insulin icodec in the EU was based on results from six phase 3 studies. The drug achieved superior performance over daily basal insulin in patients with type 2 diabetes. However, in the type 1 diabetes indication, the drug showed a similar ability to reduce blood sugar when compared to daily insulin but a higher rate of hypoglycemia.
In May this year, Novo’s competitor Eli Lilly announced positive phase 3 results for its own once-weekly insulin formulation, known as efsitora alfa, in patients with type 2 diabetes. With the FDA delaying the approval of insulin icodec, Lilly could be gaining ground in the race to launch the first weekly insulin in the US.