- 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
Synjardy tablets receive FDA approval for adults with type 2 diabetes
27 August 2015 • Author: Nick Jackson
The U.S. Food and Drug Administration (FDA) has approved Synjardy® (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, for the treatment of adults with type 2 diabetes. SYNJARDY is the third product containing empagliflozin to be approved by the FDA, following Jardiance® (empagliflozin) and Glyxambi® (empagliflozin/linagliptin).
Synjardy is a combination of empagliflozin and metformin — two medicines with complementary mechanisms of action — to help control blood glucose in people with type 2 diabetes. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.
“Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years,” said Paul Fonteyne, president and CEO, BIPI. “No two people with diabetes are alike, and every experience is different. Our alliance is proud to offer a diverse portfolio of treatments that can help patients throughout their diabetes journey.”
Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
The Synjardy label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Synjardy.
The FDA approval of Synjardy is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes.
Synjardy was also recently approved by the European Medicines Agency in May 2015.
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 ReAgent Russell Finex Limited Sentronic GmbH Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited WITec GmbH Xylem Analytics YMC Europe GmbH Yusen Logistics