Juvisync receives an FDA approval
Juvisync is a prescription medication containing sitagliptin and simvastatin. Sitagliptin is the active ingredient of the popular glucose-lowering medication Januvia, while Simvastatin is the ingredient in cholesterol-lowering medication Zocor.
According to the statistics about 20 millions of Americans suffer from both type 2 diabetes and hypercholesterolemia (high blood cholesterol levels).
The combination of these diseases is closely related to an increased risk of developing cardiovascular diseases, strokes, kidney diseases and blindness.
Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research said that Juvisync is the first combined product containing diabetes drug and statin in one tablet.
Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that helps the organism on its own to decrease elevated blood sugar levels and is approved in combination with diet and physical exercises to maintain blood sugar levels in patients with diabetes type 2.
Simvastatin belongs to statin group of drugs known as HMG-CoA reductase inhibitors, and is approved for use with exercises to lower the amount of blood LDL levels and increase HDL levels ("good cholesterol").
The approval by FDA is followed by clinical bioequivalence studies in healthy volunteers who showed that administration of Juvisync is equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and simvastatin, as separate tablets.
