Merck & Co has received a big boost after regulators in the USA gave the green light to Juvisync, which combines the firm's diabetes drug Januvia with its now-genericised cholesterol-lowerer Zocor in one tablet.
The US Food and Drug Administration has approved Juvisync (sitagliptin and simvastatin) in a variety of dosage strengths (100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg). Merck has also committed to develop combo tablets with the sitagliptin 50 mg dose and will also conduct a post-marketing clinical trial to compare how Januvia lowers glucose alone compared to Juvisync.
Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, noted that to ensure safe and effective use, tablets containing different doses of sitagliptin and simvastatin "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.”
The drugs giant said Juvisync is the first treatment approved for patients who need the blood sugar-lowering benefits of a dipeptidyl peptidase-4 (DPP-4) inhibitor, ie Januvia, and a cholesterol-lowerer in a single tablet taken once-daily. The market for the combo looks to be a considerable one, given that about 20 million people in the USA have type 2 diabetes and they often have high cholesterol levels as well.
Barry Goldstein, head of diabetes and endocrinology at Merck, said that "although clinical guidelines put people with type 2 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". The company noted that the price of Juvisync will be the same price as Januvia alone, about $215 a month.
The approval can only boost the Januvia franchise. which is already performing extremely well. In the second quarter, Januvia itself generated $779 million, up 30%, while Janumet (sitagliptin plus metformin) brought in $321 million, a leap of 47%.