Merck and Co have decided to discontinue their plans to gain approval in the US and Europe of a once-weekly DPP-4 inhibitor drug called omarigliptin.
Omarigliptin has been approved, and is in use, on the Japanese market under the trade name Marizev. However, the company no longer has plans to file for approval in other major markets such as the US and Europe.
The company state that the decision is a business decision that is not influenced by any safety issues.
Merck and Co are the manufacturers of sitagliptin under the trade name Januvia. Januvia was the first DPP-4 inhibitor to receive approval, in 2006, and is one of the most commonly prescribed drugs in this class.
Pharmaceutical news provider PMLiVE notes that Januvia, and the combination drug Janumet (Januvia and metformin) took in $6 billion of revenue last year. However, sales of the drugs have been in steady decline. One reason is that a number of new diabetes medications have hit the market, such as new GLP-1 receptor agonist medications and the newest class of drugs, SGLT-2 inhibitors.
SGLT-2 inhibitors have acquired particular interest as the drug empagliflozin (Jardiance) recently showed benefits for reducing all-cause mortality. By comparison, Januvia was not able to demonstrate a reduction in mortality in a recently published cardiovascular outcomes trial.
An addition, DPP-4 inhibitors have also recently been linked with increased risks of severe joint pain in some people and earlier this week, research on mice indicated that DPP-4 inhibitors might present an increased risk of cancer metastasis. Cancer metastasis is where a cancer migrates from one part of the body to another.

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