Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has accepted for review French pharmaceutical firm Sanofi' new drug application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin.
Subscribe to our email newsletter
The FDA acceptance follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries in May 2014.
The new drug application is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies assessing the efficacy and safety of Toujeo in more than 3,500 people from broad and diverse diabetes populations.
Sanofi senior vice president of Global Diabetes Pierre Chancel said by reaching this key milestone in the approval process, the company is happy to take another step forward with Toujeo, an investigational new basal insulin that has been evaluated in a broad range of people living with diabetes.
"With the FDA’s acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015," Chancel said.
Toujeo is the trade name for insulin glargine [rDNA origin] injection, 300 U/mL; formerly abbreviated as U300, which is not currently approved or licensed anywhere in the world.
Image: Sanofi’ NDA for Toujeo is based on results from the EDITION clinical trial program. Photo: courtesy of Baitong333/ freedigitalphotos.net