SanofiSAs new Toujeo diabetes drug won U.S. regulatory approval, but with wording on its prescribing label that analysts say could make marketing difficult.
Toujeo is a more potent follow-up to the drugmakers top-selling Lantus insulin product, which accounts for a fifth ofSanofisales.Sanofiis hoping to convert patients to Toujeo as Lantus is due to lose its U.S. patent protection this month.
The U.S. Food and Drug Administration late Wednesday approved the once daily, long-acting basal insulin to treat type 1 and the far more prevalent type 2 diabetes.
Analysts noted, however, that lower rates of hypoglycemia, a potentially dangerous drop in blood sugar, seen in clinical trials comparing Toujeo to Lantus, was not mentioned on the FDA-approved label. It also highlighted the need for higher doses to achieve the same level of blood glucose control as Lantus.