Sanofi Wins FDA Approval for New Insulin Drug Toujeo

Published: Feb 27, 2015

Sanofi Wins FDA Approval for New Insulin Drug Toujeo
February 26, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff

French biopharmaceutical company Sanofi announced on Feb. 25 that the U.S. Food and Drug Administration (FDA) has granted approval of its 300 U/mL insulin glargine injection, marketed as Toujeo. It has been approved for the treatment of adults living with type 1 and type 2 diabetes.

The approval is based on data from the EDITION clinical trial program, which looked at more than 3,500 adults living with type 1 and type 2 diabetes. EDITION is a series of international Phase III studies designed to evaluate the efficacy and safety of the drug in diabetes patients. After analyzing the data, the FDA found that the program had met its primary study endpoints by demonstrating blood sugar control.

"Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade,” said Pierre Chancel, senior vice president of Global Diabetes at Sanofi. “With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes.”

Toujeo is available in the form of a disposable pen. It is currently pending market authorization with the European Medicines Agency.

"Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and healthcare professionals due to hypoglycemia concerns,” said John Anderson, internal medicine and diabetes specialist at the Frist Clinic. “Toujeo provides a new option that may help patients manage their diabetes."

Toujeo Trumps Lantus in EDITION
In June 2014, Sanofi initially announced that Toujeo had shown that it could reduce low blood sugar rates more than Lantus, a similar product marketed by the company. In an eight-week titration period, Toujeo showed more significant reductions, which brought encouragement to researchers on the EDITION project.

"Toujeo has been recently accepted for review by EMA and this important milestone is another step forward in expanding our insulin portfolio," Chancel said at the time of the announcement. "We continue to be encouraged by the positive Phase III results from EDITION, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes."

Lantus is a once-daily injectable that provides diabetics with blood sugar control for 24 hours. It is designed for patients to use in conjunction with an existing diabetes management plan.



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