The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended the approval for French-based Sanofi’s New Drug Application (NDA) to treat type II diabetes.
The approval of the NDA has been recommended for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide in order to treat adults affected with type II diabetes.
Sanofi global research and development (R&D) president Elias Zerhouni said: "We are pleased by the Advisory Committee’s recommendation for approval of this investigational diabetes therapy.
"By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type II diabetes who are considering initiating or intensifying insulin.
"We look forward to continuing to work with the FDA as it completes its reviews of these New Drug Applications."
The NDA submission for the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide is dependent on the data collected from two Phase III studies that involved more than 1,900 adults worldwide.
Also, the NDA submission for lixisenatide depends on results from the GetGoal clinical programme that involved 13 clinical trials with more than 5,000 adults with type II diabetes.
It also included findings from the ELIXA study, which is a long-term cardiovascular (CV) outcomes study in adults affected with type II diabetes, as well as high CV risk.
Lixisenatide and the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide are under the ongoing process of FDA review, with decisions from the review expected in July and August this year, respectively.