Juvisync, the first combination pill for treatment of both type 2 diabetes and high cholesterol, has been approved for use in the US by the country’s health watchdog.
The Food and Drug Administration (FDA) has given the green light to the new drug which combines two popular medications manufactured by Merck and Co: the company’s first diabetes drug Januvia (sitagliptin) and its popular cholesterol pill Zocor (simvastatin).
Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said that to ensure safe and effective use, tablets containing different doses of Januvia and Zocor "have been developed to meet the different needs of individual patients".
She added that "dose selection should factor in what other drugs the patient is taking."
Merck said Juvisync is the first treatment approved for patients who need the blood sugar-lowering benefits of a dipeptidyl peptidase-4 (DPP-4) inhibitor and a cholesterol-reducer in a single, once-daily tablet.
The New Jersey-based pharmaceutical added that it will conduct a post-marketing clinical trial to compare how Januvia lowers glucose alone compared to Juvisync.
An estimated 20 million people in the US suffer from type 2 diabetes and many of those also have high cholesterol, putting them at greater risk of heart disease, stroke, kidney disease and blindness .
First Diabetes-Cholesterol Combo Drug Gets FDA Approval
Mon, 10 Oct 2011
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