Novo Nordisk Pursues FDA Filing for Once-Weekly Insulin and Semaglutide Combo After Icodec Rejection

FDA Rejection:
The FDA rejected Novo Nordisk's once-weekly insulin icodec due to manufacturing issues and concerns about its efficacy in type 1 diabetes.

New Filing Plans:
Despite the rejection, Novo Nordisk plans to file for regulatory approval for a combination therapy called IcoSema, which pairs insulin icodec with semaglutide, by the end of 2024.

COMBINE-1 Study:
The pivotal Phase III COMBINE-1 study showed that IcoSema achieved superior blood sugar control and weight loss compared to insulin icodec alone in type 2 diabetes patients.

Safety and Tolerability:
The combo therapy demonstrated a lower rate of clinically significant hypoglycemia and was found to be safe and well-tolerated.

Market Context:
The move aims to revitalize Novo Nordisk's GLP-1 inhibitor semaglutide, which faces competition from Eli Lilly's tirzepatide products.