EMDAC recommends NDA approval for Sanofi’s type 2 diabetes treatment
Posted: 26 May 2016 | | 1 comment
The FDA’s EMDAC has recommended the approval of the NDA for the fixed-ratio combination of insulin glargine and lixisenatide…
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and Sanofi’s lixisenatide for the treatment of adults with type 2 diabetes.
The 15-member panel voted 12 to 2 to approve the fixed-ratio combination of insulin glargine and GLP-1 receptor agonist lixisenatide.
Commenting on the announcement, Elias Zerhouni, President, Global R&D, Sanofi, 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 2 diabetes who are considering initiating or intensifying insulin.”
NDA submission based on two Phase III studies
The NDA submission for the fixed-ratio combination of insulin glargine and lixisenatide is based on data from two Phase III studies that evaluated the efficacy and safety of the combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy. Both studies met their primary endpoints.
The NDA submission for lixisenatide is based on results from the GetGoal clinical programme, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes. The NDA submission for lixisenatide also includes findings from the ELIXA study, a long-term cardiovascular (CV) outcomes study in adults with type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).
Lixisenatide and the fixed-ratio combination of insulin glargine and lixisenatide are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. The fixed-ratio combination of insulin glargine and lixisenatide was also submitted for regulatory review in the European Union in March 2016.