Merck augments Januvia franchise with statin combo

Merck ($MRK) just extended its Januvia franchise with the FDA approval of Juvisync, a combination pill comprised of the company's diabetes drug and its now-off-patent cholesterdol pill Zocor (simvastatin). The new drug allows Merck to target patients with Type 2 diabetes and high cholesterol, conditions that often arise in tandem.

Juvisync joins a family of two other drugs: Januvia, a DPP-4 inhibitor used to help control blood sugar in diabetes patients, and Janumet, which combines Januvia with a commonly used first-line diabetes treatment, metformin. The combination of a diabetes remedy with a statin drug is unique, however. It comes in several fixed-dose combinations to treat a variety of patients, FDA said; the first available will combine 100 mg of Januvia with 10, 20 or 40 mg of simvastatin. Merck says it will develop three other strengths based on 50 mg of Januvia.

The company has also agreed to conduct post-marketing studies comparing blood-sugar control in patients on Januvia alone and in patients on the combination drug. FDA said it "has recently become aware" of the potential for statins to boost blood sugar in Type 2 diabetes patients, but that the risk appears "very small."

The potential market for Juvisync is quite large, Merck figures. The company estimates there are 6 million to 8 million Type 2 diabetes patients who should be using a statin drug, but are not, Reuters reports. The American Diabetes Association recommends statins for diabetes patients with heart disease, irrespective of whether they have high cholesterol, and for diabetes patients over the age of 40 who have cardiovascular risk factors. No word yet from analysts about potential sales, but Januvia brought in $779 million during the second quarter, a 30% increase.

- read the statement from FDA
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