Global pharmaceutical company Sanofi's investigational combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist, lixisenatide, is one step closer to approval, as it has been accepted for review by the U.S. Food and Drug Administration (FDA).
Sanofi forwarded a New Drug Application (NDA) to the FDA for the combination, which is indicated for treatment of adults living with type 2 diabetes. The FDA has granted the potential therapy priority review; a decision about its approval is expected in August, if not sooner.
"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," Pascale Witz, executive vice president of global diabetes for Sanofi, said. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes -- and additional treatment options are needed. 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 U.S."
The glargine and lixisenatide combination was the subject of two separate phase-three international studies that used as subjects more than 1,900 patients who had been diagnosed with type 2 diabetes.
Primary endpoints were achieved by both studies. More detailed results will be presented by Sanofi researchers later this year at a health care conference.
