Solvay submits Synordia® ( fenofibrate/ metformin) for EU approval
Building out the fenofibrate franchise with a new fixed-dose combination product
Solvay announced today that it has submitted its dossier for SYNORDIA®1 to the European Medicines Evaluation Agency on 17 July 2006 for a centralized approval procedure. SYNORDIA® is a fenofibrate/metformin fixed-dose combination product.
It would be the first product on the market that combines a lipid lowering drug with an oral antidiabetic in one pill, targeting increased patient convenience and improved compliance for patients already stabilized on the two medications, fenofibrate and metformin which can control both the blood lipids and blood glucose of patients.
The clinical Phase III program, carried out in more than 1000 patients, demonstrated that SYNORDIA® is efficacious and is well accepted. Previous trials (DAIS and FIELD) have also indicated that the combination therapy of fenofibrate/metformin has benefits for type 2 diabetic patients.
“SYNORDIA® would represent a valuable treatment option for many type 2 diabetic patients, improving the quality of life for many men and women who struggle with this disease on a daily basis. It reduces the number of tablets they need to take each day. Moreover, it is an important addition to the range of fenofibrate treatments we offer”, said Werner Cautreels, CEO of Solvay Pharmaceuticals.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men’s and women’s health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10000 people worldwide. For more information, visit solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext : SOLB.BE – Bloomberg: SOLB.BB – Reuters: SOLB.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com
Notes to the editor:
DAIS=Diabetes Atherosclerosis Intervention Study (2001),418 patients received treatment with fenofibrate (or placebo) for 3 years. The study gave first evidence that fenofibrate could prevent cardiovascular morbidity/mortality in type 2 diabetes patients.
FIELD=Fenofibrate Intervention and Event Lowering in Diabetes in 9795 patients (2005), about one third receiving fenofibrate (or placebo) and metformin.