Sanofi Type 2 Diabetes Drug Recommended for FDA Approval
Lixisenatide is an investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist for adults with type 2 diabetes.
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recently recommended approval of the new drug application (NDA) for an investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for adults with type 2 diabetes.
The NDA submission was based on a pair of phase 3 trials that enrolled more than 1900 adults worldwide to test the safety and efficacy of the fixed-ratio combination of insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide when used in populations insufficiently controlled after oral antidiabetic agents (OADs) and insulin therapy, respectively.
Both studies met their primary endpoints. The NDA submission for lixisenatide was based on results from the GetGoal clinical program. The program included 13 clinical trials with more than 5000 adults diagnosed with type 2 diabetes.
The submission also included data findings from the long-term cardiovascular (CV) outcomes study for adults with type 2 diabetes and high CV risk, called the ELIXA study.
“We are pleased by the Advisory Committee's recommendation for approval of this investigational diabetes therapy,” said Elias Zerhouni, President, Global R&D, Sanofi. “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 2 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.”
At this time, the fixed-ratio combination of insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide is under FDA review and a decision is expected to be made in July and August of this year.