Fixed-Ratio Combination Treatment for Diabetes Under Review

Article

The FDA has accepted for review Sanofi's new drug application for its fixed-ratio combination of basal insulin glargine 100 units/mL and lixisenatide for the treatment of type 2 diabetes.

The FDA has accepted for review Sanofi’s new drug application for its once-daily fixed-ratio combination of basal insulin glargine 100 units/mL and lixisenatide for the treatment of type 2 diabetes.

Sanofi can expect the FDA’s decision by August 2016.

The new drug application was based on data from 2 phase 3 studies involving more than 1900 patients. The trials evaluated the safety and efficacy of the fixed-ratio combination in helping patients with insufficiently controlled type 2 diabetes after the use of oral antidiabetic agents and basal insulin therapy.

Both studies met their primary endpoints.

"Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed,” said Pascale Witz, executive vice president of Global Diabetes & Cardiovascular at Sanofi, in a press release. “We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the United States."

Related Videos
Female Pharmacist Holding Tablet PC - Image credit: Tyler Olson | stock.adobe.com
African American male pharmacist using digital tablet during inventory in pharmacy - Image credit: sofiko14 | stock.adobe.com
Young woman using smart phone,Social media concept. - Image credit: Urupong | stock.adobe.com
selling mental health medication to man at pharmacy | Image Credit: Syda Productions - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Image credit: rawpixel.com | stock.adobe.com
Medical team -- Image credit: Flamingo Images | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.