Merck’s diabetes combo pill gets FDA nod

The U.S. Food and Drug Administration (FDA) has approved Merck & Co.’s Juvisync diabetes drug, a combination pill for type 2 diabetes. Juvisync combines two Merck drugs already on the market, 1) glucose-lowering Januvia (Sitagliptin) medication and 2) cholesterol-lowering Zocor (Simvastatin).

As a result of this combo the medication costs would be reduced to the price of one. In addition, there will be six different dosage strengths, so it can accommodate the needs of the patient with varying levels of cholesterol and diabetes. The combo in fact will sell for the same price as Januvia alone, about $215 per month. Zocor’s generic version will cost about $30 a month. Thus Juvisync should become more popular among millions of people with diabetes who are not taking a statin, including Zocor.

According to the American Diabetes Association, statin therapy for patients who has both diabetes and cardiovascular disease proves to be beneficial. They are recommending statins for patients older than 40 years old with diabetes and with cardiovascular disease risk factors, such as high blood pressure. Merck’s medical experts say that about six to eight million of the type 2 diabetics should be on a statin therapy, but are currently not receiving it. Thus they hope Juvisync will fill with medication gap.

Additionally, more than 25 million people with diabetes also have high cholesterol in the U.S. This could be due to both conditions being linked to being overweight. Having both diabetes and high cholesterol increases the risk of heart disease, stroke, kidney disease and other chronic conditions. About 65% of people with diabetes die from heart disease and stroke.

“Although clinical guidelines put people with diabetes at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment,” said Dr. Barry Goldstein, Merck's vice president for diabetes and endocrinology, in a news release. “We are proud to bring forward a treatment option that can help address this important health issue.”

“Perhaps one third of the nation’s eligible patients with type 2 diabetes are not being treated with a statin, so here’s a convenient tool for doctors to target glucose as well as cholesterol levels,” Dr. Sethu Reddy, Merck’s director of clinical affairs for diabetes, said in a statement.

This combination pill will also simplify medication regimen and improve adherence to the treatment. Instead of taking a handful of different pills, patients who take Juvisync will need to take fewer pills, improving adherence. Improving adherence could lead to reduced future health care costs because patients are able to manage their medication better say experts.

“This provides a way to simplify their regimen and improve adherence,” said Dr. Susan Spratt, an endocrinologist at Duke University Medical Center. Spratt said many diabetes patients are taking six or more pills a day, including different types of pills for diabetes, blood pressure and high cholesterol. It can be hard to consistently take them all at the right time, and even with health insurance, patients’ out-of-pocket costs for their medications and diabetes testing supplies can be very high. “Anything to reduce the cost is going to be helpful to patients,” Spratt said, adding, “When you improve medication adherence, you actually lower health care costs because patients don’t end up in the ER or the hospital.”

The side effects are usually mild, including stuffy nose and sore throat, headache, muscle and stomach pain. Juvisync, a probable blockbuster developed by Merck & Co. Inc., will be launched in a few weeks. Merck, based in Whitehouse Station, N.J., is planning to seek approval of Juvisync in many other countries in the near future, according to spokeswoman Pam Eisele.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

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