US approval for Merck’s Januvia-Zocor combination
pharmafile | October 10, 2011 | News story | Sales and Marketing | Januvia, Juvisync, Zocor
US regulators have given the green light to the latest in Merck & Co’s stable of brands aimed at type II diabetes sufferers.
Juvisync (sitagliptin and simvastatin) tablets have been approved by the FDA as a once-daily treatment for patients who need to lower both blood sugar and cholesterol.
A combination of Merck’s own glucose-lowering drug Januvia (sitagliptin) and its anti-cholesterol brand Zocor (simvastatin), Juvisync therefore helps patients who need both glycemic and lipid therapy and will cost the same as Januvia on its own.
It is the first time that type II diabetes and cholesterol lowering drugs have been put together in one tablet, and Merck will have to conduct a post-marketing clinical trial comparing the glucose-lowering ability of Januvia alone compared to Juvisync.
The recommended starting dose is 100/40 mg sitagliptin/mg simvastatin per day although the FDA also warns that dose selection should factor in what other drugs the patient is taking.
There will be no combination involving simvastatin 80mg, since there is a higher risk of muscle toxicity at this dosage level.
And while there is potential for statins to increase blood sugar levels in patients with type II diabetes – a point that Juvisync’s prescribing information will make – the FDA says this small risk is outweighed by the benefits of statins for reducing heart disease in diabetes.
Dipeptidyl peptidase 4 (DPP-4) inhibitor Januvia enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycaemic control.
Zocor is used, again with diet and exercise, to reduce the amount of ‘bad’ cholesterol (low-density lipoprotein cholesterol) in the blood.
“Although clinical guidelines put people with type II diabetes who need glycaemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40% of eligible patients do not receive statin treatment,” said Barry Goldstein, vice president, diabetes and endocrinology at Merck.
In the US there are around 20 million people who have type II diabetes and they often have high cholesterol levels as well.
Adam Hill
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