In surging to the top spot in the market cap rankings in Europe, Novo Nordisk has been on an extended winning streak. But the FDA has slowed the roll for the Danish company, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes.
In a complete response letter (CRL), the U.S. regulator made "requests related to the manufacturing process and the type 1 diabetes indication," the company said, adding that it does not expect to remedy the issues by the end of this year.
Seven weeks ago, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave icodec a thumbs-down, raising questions about its potential to cause low blood sugar. Seven of 11 panelists agreed that the data presented were not sufficient to conclude that the benefits of icodec outweighed the risks for adults with Type 1 diabetes. The committee did not vote on icodec’s suitability for Type 2 diabetes patients.
Under the brand name of Awiqli, insulin icodec has been approved for Type 1 and Type 2 diabetes in Europe, Canada, Japan and Australia. It also has been endorsed in China for Type 2 diabetes.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” Martin Lange, M.D., Ph.D., Novo’s development chief, said in a release. “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.”
The rejection comes as Novo’s diabetes rival Eli Lilly runs trials for its once-weekly insulin product. Two months ago, Lilly reported positive top-line data for two phase 3 studies of efsitora alfa that showed it performed comparably to daily insulin injections in patients with Type 2 diabetes.
The insulin battle is small potatoes compared to the war Novo and Lilly are waging for their GLP-1 products for Type 2 diabetes and obesity.
Less than three weeks ago, Novo revealed a plan to build a $4.1 billion plant in North Carolina that would produce its megablockbusters Ozempic and Wegovy. That announcement came a month after Lilly unveiled a $5.3 investment to increase its manufacturing capacity for diabetes drug Mounjaro and obesity treatment Zepbound.
Novo's GLP-1 diabetes medicine Ozempic generated about 95.7 billion Danish kroner ($13.8 billion) last year, compared with 48 billion Danish kroner ($7 billion) for the company's entire insulin portfolio.