FDA clears Merck's Januvia, sister meds of new pancreatitis worries

Merck ($MRK) can relax now. The FDA says it's not worried about a new study linking pancreatitis with the company's big diabetes drug Januvia and other drugs in its category. The group of drugs, known as incretin mimetics, was cleared last week by the FDA's counterparts in Europe.

The FDA tells Pharmalot that it concurs with the EMA's conclusions about the drugs and sees no need to change the official labeling about potential safety risks, at least right now. "FDA's review is ongoing as pancreatitis and pancreatic cancer data are being collected" in ongoing outcomes trials looking at the drugs' impact on cardiovascular health in diabetics, an agency spokeswoman told Pharmalot.

The list of incretin mimetic drugs includes a handful of therapies besides Januvia, including Novo Nordisk's ($NVO) blockbuster Victoza and Bristol-Myers ($BMY) and AstraZeneca's ($AZN) Onglyza and Byetta. But the safety worries have been a drag on Merck's stock, especially considering the company's reliance on Januvia sales as it suffers from generic rivals to its once-top-selling Singulair. ISI Group analyst Mark Schoenebaum called the safety worries "one of the key overhangs" on Merck's stock. Now that the FDA has spoken, he said in a note this morning, "I would view this overhang as largely dead."

The FDA has already flagged worries about pancreatitis on Januvia and Byetta's labels, so the questions aren't entirely new. But the latest debate over potential links between these meds and pancreatitis and, in turn, pancreatic cancer, began earlier this year, with a new study that analyzed insurance records to find that patients hospitalized with pancreatitis were twice as likely to be using Januvia or Byetta, compared with diabetes patients who didn't have pancreatitis. It appeared to be a clearer association than previous reports had shown.

The EMA said its experts dug into the data and found "methodological limitations and potential sources of bias" and decided the available data don't bear out worries about an increased risk of "pancreatic adverse events." The communique affected the entire group of incretin mimetics, which comprises GLP-1 agonists, which mimic a key hormone, and DPP-4 inhibitors, which interfere with a protein that breaks down the same hormone.

- see the report from Pharmalot

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