FDA Approves Combo Drug That Treats Both Diabetes, High Cholesterol

The FDA today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet, making if it the first combination drug approved to treat type 2 diabetes and high cholesterol.

Merck’s Juvisync combines sitagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s ability to lower elevated blood sugar, and simvastatin, an HMG-CoA reductase inhibitor that reduces levels of low-density lipoprotein cholesterol.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” Mary H. Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. Merck has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80-mg dose because of a higher risk of muscle toxicity, there will not be an FDC using this dose.

The FDA stated that the new FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. The agency added that Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

In a statement, the FDA said is has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes, but added that the risk appears to be very small and is outweighed by the benefits of statins for reducing heart disease in diabetes.

The prescribing information for Juvisync will inform doctors of this possible side effect. Merck will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

SourceFDA Approves Combination Therapy Juvisync [FDA]