Merck, Novo Nordisk Join Post-Market Diabetes Study Efforts: “Drug Safety Is Paramount”

Novo Nordisk, Pfizer, BMS, Merck and others will join an independent review of the entire of class of on-market diabetes drugs. That is the right thing to do, and smart management.

It will take some time, but I suspect that the class will be cleared of the suspicion that elevated precancerous cell growth in the pancreas is related to the drugs.

Here is a bit from the Whitehouse Station version of the related press releases:

. . . .“Nothing is more important to Merck than the safety of our medicines and the people who take them. We welcome opportunities to discuss the data that support the safety profile of sitagliptin in the treatment of adults with type 2 diabetes. Type 2 diabetes is a disease with serious consequences if left untreated,” said Michael Rosenblatt, M.D., chief medical officer, Merck. “We are committed to participating in an independent review of our data, and will join the ADA in planning for such an initiative.”

Merck will participate in the NIDDK-NCI Workshop on Pancreatitis-Diabetes-Pancreatic Cancer that starts today. During the meeting, Merck researchers will present data and the company’s perspective on the safety profile of sitagliptin, including an updated analysis of data in more than 14,000 patients from 25 randomized clinical trials of sitagliptin that was recently published. . . .

As I’ve written before, J&J’s recently-approved Invokana® (acting via a different mechanism) may well gain lots more market share, if the study fails to clear the GLP-1 and DPP-4 inhibitor class, of pre-cancerous cell safety concerns. Stay tuned.

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