FDA Rejects Novo Nordisk's Weekly Insulin Over Manufacturing Issue

Novo Nordisk, a leading pharmaceutical company, has recently faced a setback in the United States. Although the company received approvals for its once-weekly insulin icodec in Europe, Canada, and Japan, the U.S. Food and Drug Administration (FDA) has rejected it due to manufacturing issues.

Novo Nordisk has enjoyed a remarkable period of success, climbing to the top of market capitalization rankings in Europe. However, this momentum was halted by the FDA’s decision to issue a complete response letter (CRL). The letter cited concerns related to the manufacturing process and the application for treating Type 1 diabetes. The company has indicated that these issues will not be resolved by the end of the year.

This FDA rejection follows an earlier recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which raised concerns about the potential risks of low blood sugar associated with icodec. A majority of the committee members believed that the data was insufficient to demonstrate that the benefits of icodec outweighed its risks for adults with Type 1 diabetes. The committee did not evaluate the suitability of icodec for Type 2 diabetes patients.

Despite this setback in the U.S., insulin icodec, marketed under the brand name Awiqli, has received approval for both Type 1 and Type 2 diabetes in various countries including Europe, Canada, Japan, and Australia. Additionally, it has been endorsed in China specifically for Type 2 diabetes.

Martin Lange, M.D., Ph.D., Novo Nordisk’s development chief, expressed optimism about the potential of insulin icodec for patients who need basal insulin therapy. He emphasized the company’s commitment to working closely with the FDA to address the issues and complete the review process, with the aim of making this novel treatment available to adults living with diabetes.

Meanwhile, Novo Nordisk's competitor, Eli Lilly, is also making strides in the diabetes market. Eli Lilly is conducting trials for its own once-weekly insulin product. Recently, Lilly reported favorable top-line results from two phase 3 studies of efsitora alfa, which demonstrated comparable performance to daily insulin injections in patients with Type 2 diabetes.

The competition between Novo Nordisk and Eli Lilly extends beyond insulin products to their GLP-1 drugs for Type 2 diabetes and obesity. Both companies are heavily investing in expanding their manufacturing capacities. Less than three weeks ago, Novo Nordisk announced plans to build a $4.1 billion plant in North Carolina to produce its blockbuster drugs Ozempic and Wegovy. This announcement followed Eli Lilly’s recent investment of $5.3 billion to increase manufacturing capacity for its diabetes drug Mounjaro and obesity treatment Zepbound.

Novo Nordisk’s GLP-1 diabetes medication, Ozempic, generated approximately 95.7 billion Danish kroner ($13.8 billion) last year, significantly outpacing the company's entire insulin portfolio, which brought in 48 billion Danish kroner ($7 billion). This highlights the growing importance of GLP-1 products in the company’s revenue stream.

In conclusion, while Novo Nordisk faces challenges in gaining U.S. approval for its once-weekly insulin icodec, the company continues to thrive in other markets and remains a major player in the global diabetes and obesity treatment landscape.