Merck’s $4 Billion Diabetes Drug in Trouble?

For the past two months, there has been rising controversy over the extent to which certain diabetes drugs called GLP-1 inhibitors may cause pancreatitis and pancreatic cancer. Although links to pancreatitis are actually not new, one of two recent papers suggested pre-cancerous cell growth may be cause for concern, prompting both the FDA and the European Medicines Agency to start investigations.

Now, a watchdog group is calling for a reassessment of the entire class of drugs after analyzing adverse events data that was reported to the FDA and finding distinctly higher odds that GLP-1 drugs are generating reports for these illnesses compared with a control group consisting of older drugs, such as metformin, that are used to treat diabetes.

Specifically, the analysis found the odds were roughly 25 times higher for the following drugs: Merck’s Januvia (MRK), which is the biggest seller in this group; Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also marketed by Bristol-Myers; the Tradjena treatment sold by Eli Lilly (LLY) and Boehringer Ingelheim, and Novo Nordisk’s (NVO) Victoza.

“I think the future of the whole class is in question,” says Tom Moore, senior scientist for drug safety and policy with the Institute for Safe Medication Practices, which published the data in its QuarterWatch report. While he says further study should be undertaken, “if results are confirmed in a broader patient population, it raises questions about the entire class of drugs.”

Big drug makers have had a hard time of late generating revenue growth, due to patent expirations on existing medicines and the failure of company labs to produce enough new medicines.

MRK Revenue TTM Chart

MRK Revenue TTM data by YCharts

To read the remainder of this article, go to Pharmalot.

Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at editor@ycharts.com.

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