Sanofi's new Toujeo diabetes drug has won U.S. regulatory approval but with wording on its label that analysts say could make marketing difficult.
Toujeo is a more potent follow-up to the French drugmaker's top-selling Lantus insulin product, which accounts for a fifth of group sales and is due to go off U.S. patent this year.
The Food and Drug Administration on Wednesday approved the new once-daily, long-acting basal insulin to treat adults with both type 1 and the far more prevalent type 2 diabetes.
Analysts noted, though, that some potential benefits were not mentioned on the FDA-approved label, which also highlighted the need for higher doses to achieve the same level of glycemic control.
"The Toujeo label is probably going to be viewed as more undifferentiated than investors have been expecting," Bernstein analysts, who rate the stock "outperform", said in a research note. Citi analysts called the label "not great."
In addition to gaining Toujeo patients through conversions, "there's about a million new patients for basal insulin each and every year," said Joe Balzer, head of U.S. commercial operations for Toujeo, which is awaiting a European approval decision.
Toujeo has the same active ingredient as Lantus, called insulin glargine, but at three times the concentration and with a design to release the insulin more gradually.
The medicine provides similar blood glucose control as Lantus with significantly lower rates of hypoglycemia, a potentially dangerous drop in blood sugar.
Lantus is the world's most prescribed insulin with sales of $7.2 billion in 2014. Warnings of faltering U.S. Lantus sales contributed to the sudden sacking of Sanofi Chief Executive Officer Chris Viehbacher last year.
His successor, Olivier Brandicourt, is set to assume the top post at the beginning of April as Toujeo goes on sale.
The company has not revealed a Toujeo price and declined to discuss any potential discounting strategy in a market analysts see becoming increasingly price sensitive.
More than 370 million people worldwide have diabetes, the International Diabetes Federation says. As many as 95 percent have type 2, often associated with obesity and which raises the risk of numerous serious health problems.
© 2026 Thomson/Reuters. All rights reserved.