FDA Delays Approval of Novo Nordisk's Once-Weekly Insulin Icodec

FDA Delays Approval of Novo Nordisk's Once-Weekly Insulin Icodec

By, Admin 15 July 2024

Overview

Novo Nordisk does not expect to be able to fulfill the FDA’s requests during 2024.The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Novo Nordisk covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus.

Manufacturing Process & Diabetes Indication

  • In the letter, the FDA makes requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. 
  • Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. 
  • Novo Nordisk does not expect to be able to fulfill the requests during 2024.

Words from EVP: Novo Nordisk

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.

Application submission to FDA

  • Novo Nordisk submitted the application for insulin icodec to the FDA in April 2023. 
  • In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes. 
  • The panel determined that the data available were not sufficient to conclude on a positive benefit-risk in type 1 diabetes. 
  • The Advisory Committee did not discuss the use of once-weekly insulin icodec in type 2 diabetes.

Insulin Icodec: Approval

Insulin icodec is approved under the brand name Awiqli in the EU, Canada, Australia, Japan and Switzerland for the treatment of both type 1 and type 2 diabetes and in China for the treatment of type 2 diabetes.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!