Novo Nordisk’s Once-Weekly Insulin Icodec Faces FDA Rejection and Manufacturing Concerns

FDA Rejection:
The FDA has rejected Novo Nordisk's biologics license application for icodec, a once-weekly insulin, due to concerns about the manufacturing process and its use in type 1 diabetes patients.

Manufacturing Issues:
The FDA raised questions about the manufacturing process for icodec, which Novo Nordisk does not expect to address this year.

Type 1 Diabetes Concerns:
The FDA advisory committee concluded that the available data were insufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes, citing higher rates of hypoglycemia compared to daily insulin injections.

International Approvals:
Icodec is approved in Europe, Canada, Australia, Japan, and Switzerland for both type 1 and type 2 diabetes, and in China for type 2 diabetes only.

Future Plans:
Despite the FDA rejection, Novo Nordisk plans to file for regulatory approval for a combination of icodec and semaglutide, known as IcoSema, for type 2 diabetes by the end of 2024.

IcoSema Efficacy:
The COMBINE-1 study showed that IcoSema achieved superior blood sugar control and weight loss compared to icodec alone, with a lower rate of severe hypoglycemia.

Competitive Landscape:
Eli Lilly is developing a rival once-weekly insulin called efsitora alfa, which has shown promising results in clinical trials for type 2 diabetes.