Sanofi recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for the fixed-ratio combination of basal insulin glargine (100 Units/mL) and lixisenatide as a therapy for adult patients with type 2 diabetes, whose blood glucose is insufficiently controlled with oral antidiabetic agents (OADs) and basal insulin therapy. The insulin glargine plus lixisenatide combined therapy is administered by subcutaneous injection once daily.
Following a priority review, an FDA decision regarding approval is expected for August 2016.
“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 & Cardiovascular at Sanofi, said in a press release. “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 NDA submission was based on the results from two Phase 3 clinical trials evaluating the efficacy and safety of the combination therapy, involving over 1,900 patients worldwide. The two trials met their primary endpoints, and the results are to be presented in an upcoming medical meeting.
No regulatory authority has so far evaluated the safety and efficacy of the insulin glargine plus lixisenatide as a combination therapy, and the treatment’s proprietary name is still under consideration. A regulatory submission to the European Union in expected for March 2016.
Lixisenatide was assessed in type 2 diabetes patients and is under review by the FDA. In September 2015, the FDA accepted the NDA for lixisenatide and a decision is anticipated in July 2016.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Insulin glargine is a long-acting basal insulin analogue used to help control blood sugar levels in diabetic patients.