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FDA Okays Merck's Blood Sugar, Cholesterol Lowering Drug Juvisync

The US Food and Drug Administration Friday approved Merck & Co. Inc.'s (MRK) Juvisync, the first ever treatment for type 2 diabetes patients who need to lower blood sugar and cholesterol levels.

Juvisync combines the glucose-lowering medication sitagliptin, the active component of Merck's third best-selling drug Januvia, with the cholesterol-lowering medication simvastatin.

In Merck's second quarter, sales of Januvia totaled $779 million, up 30 percent from last year.

Merck said the price of Juvisync will be the same price as Januvia alone, and will be available in pharmacies in the near future.

The FDA approved Juvisync based upon clinical bioequivalence studies that showed administration of Juvisync is equivalent to co-administration of corresponding doses of sitagliptin and simvastatin as separate tablets.

Sitagliptin is a dipeptidyl peptidase 4, or DPP-4 inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of bad cholesterol.

Juvisync becomes the first treatment option that provides the blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single tablet once daily.

"Although clinical guidelines put people with type 2 diabetes who need glycemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," said Barry Goldstein, vice president, Diabetes and Endocrinology, Merck.

"We are proud to bring forward a treatment option that can help these patients who need both glycemic and lipid therapy."

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg.

Merck said it has committed to develop Fixed Dose Combination tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg.

Type 2 diabetes is estimated to affect about 20 million people in the US, and is often accompanied by high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions.

MRK closed Friday's regular hours at $31.61, up $0.19 or 0.60%, on a volume of 21.87 million shares on the NYSE. In after hours, the stock gained 1.23%.

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