The US Food and Drug Administration has approved Sanofi’s new diabetes drug formulation Toujeo (insulin glargine injection, 300 U/mL). The drug, which may be used by patients with either type 1 or type 2 diabetes, is a once-daily long-acting basal insulin.
The new drug is a triple dose of the insulin glargine found in Sanofi’s existing diabetes drug Lantus (100 U/mL). Designed to release insulin more slowly, Tuojeo was better at modulating nighttime hypoglycemia than Lantus, according to results from the EDITION clinical trial program. The EDITION trial evaluated the efficacy and safety of Toujeo compared to Lantus in more than 3500 adults with type 1 or type 2 diabetes, all with uncontrolled diabetes on their current therapy,
Toujeo is expected to be available in the United States in early April. In February, Lantus was to lose its patent protection. Analysts say that Sanofi, however, may have to work very hard to persuade Lantus users to make the switch to Toujeo.
Toujeo’s clinical advantages are not found on US labeling, according to Fierce Biotech analyst Tim Anderson. Europe’s different labeling rules allow the advantages to be noted.
In addition, Novo Nordisk’s long-acting diabetes drug Tresiba is approved for use in Europe, creating a crowded marketplace for big diabetes drug companies, Reuters noted. While the FDA rejected a Novo bid for approval in February 2013 with a directive for more testing, Novo said it would submit interim results with an eye toward a potential launch in 2016.
