The FDA has given a nod of approval for the combination drug Juvisync (sitagliptin and simvastatin, Merck), which is indicated for patients with type 2 diabetes and high cholesterol.
The fixed-dose combination (FDC) drug is approved for use in patients who need both sitagliptin and simvastatin. According to the FDA, 20 million people in the U.S. are diagnosed with type 2 diabetes; many of these patients also have high cholesterol levels.
Sitagliptin is a dipeptidyl peptidase 4 inhibitor that works to lower blood sugar. The drug is approved for use in combination with diet and exercise to improve glycemic control in type 2 diabetics. Simvastatin is also approved for use with diet and exercise to reduce 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.”
The FDA approved Juvisync in the following dosages: sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. Merck said that it will develop FDC tablets with sitagliptin 50 mg dose as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. The FDA said that patients requiring the 50 mg dose of sitagliptin should continue to use the single ingredient sitagliptin tablet.
The company will not develop FDCs for the 80 mg dose of simvastatin due to the higher risk of muscle toxicity found by the FDA, which resulted in changes to the drug's label.
Lastly, FDA offered that while it is aware of the potential of statins to increase blood sugar levels in type 2 diabetic patients, the agency said that the risk is small and outweighed by the benefits of statins for reducing heart disease in diabetics.
Merck will be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin administered with simvastatin.
Juvisync is manufactured by MSD International Clonmel in Tipperary, Ireland.