Fixed-Ratio Combination Treatment for Diabetes Under Review
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."