- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
EMDAC recommends NDA approval for Sanofi’s type 2 diabetes treatment
26 May 2016 • Author: Victoria White, Digital Content Producer
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.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics