Merck Discontinues Diabetes Combo Drug

Type 2 diabetes and cholesterol combination drug no longer in development by Merck

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) A drug that would have been a combination treatment for diabetes and high cholesterol will no longer be developed, according to an article in the Wall Street Journal.

Merck & Co. announced that it has stopped development of MK-0431E, a pill that would combine the company's diabetes drug Januvia (sitagliptin) with the commonly used cholesterol drug Lipitor (atorvastatin).

Merck cited unspecified business reasons for discontinuing development of the drug.

"Ask your doctor about treatment options for your diabetes."

Pam Eisele, a spokeswoman for Merck, said on Tuesday that the decision to stop developing the combination drug was not due to safety concerns.

This is the second time in the past few months that Merck halted development of a combination drug. The company stopped making a drug that combined the two cholesterol medications niacin and Zocor (simvastatin). According to Merck, the market conditions were not good enough to continue developing the drug.

Januvia is a tablet taken once a day to lower blood sugar levels in patients with type 2 diabetes. It is Merck's top-selling drug. In the first 9 months of this year, the drug made $2.95 billion in sales.

Januvia went on sale in 2006. Since then, Merck has combined a number of other drugs with Januvia. Last year, for example, the FDA approved Merck's drug Juvisync - a combination of Januvia and Zocor to lower levels of bad cholesterol.

Zocor is a statin drug that was Merck's best-selling product before the introduction of Januvia.

The MK-0431E drug was meant to be similar to Juvisync, except it would combine Januvia with Lipitor - a more widely used statin.

In 2011, the drug manufacturer Pfizer lost exclusive rights to Lipitor. By developing MK-0431E, Merck had hoped to take advantage of the newly available Lipitor.

Patients with type 2 diabetes have an increased risk of heart-related problems. Merck intended this new combination drug to be a treatment for both type 2 diabetes and the heart-related complications these patients may face.

In 2011, the drug was in the late stages of testing. Merck planned on filing an application for FDA approval in 2014.

Merck still plans to use Lipitor with another one of the company's cholesterol-fighting drugs called Zetia (ezetimibe). However, the FDA refused to approve this combination drug earlier this year. The FDA said that it needed more information, which Merck plans to provide by the end of this year.

Reviewed by: 
Review Date: 
November 13, 2012
Last Updated:
November 14, 2012