Diabetes Drugs’ Pancreas Risk Not Backed by Evidence: EMA

A European Medicines Agency committee didn’t find enough evidence to support scientists’ concerns that a class of diabetes drugs known as GLP-1s affect pancreatic cell growth, the regulator said today.

“Available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines,” the London-based agency said in a statement. The EMA’s Committee for Medicinal Products for Human Use, or CHMP, had started its review of the therapies in March.

GLP-1-based medicines approved for use in the European Union include Bristol-Myers Squibb Co.’s Byetta, Novo Nordisk A/S’s Victoza and Merck & Co.’s Januvia. Researchers at the University of California, Los Angeles found increased pre-cancerous changes in diabetes patients using this class of drugs, the Washington-based public advocacy group Public Citizen said when the research was published.

The CHMP reviewed the evidence, consulted experts and determined that the study had limitations, potential sources of bias and other factors that prevented “a meaningful interpretation of the results,” the EMA said. The committee concluded that there was no change in the evidence for risks of harm to the pancreas from using GLP-1 drugs.

The increase in Type 2 diabetes cases represents a “major public health challenge,” the regulator said. Manufacturers of the diabetes treatments “are closely monitoring for adverse effects, including effects on the pancreas, and report their findings regularly.”

Merck’s chief medical officer, Michael Rosenblatt, said the EMA’s investigation concluded there was no new evidence about the safety of the diabetes drugs, including Januvia, which is also known at sitagliptin.

“We are confident in the safety profile of sitagliptin,” Rosenblatt said in an e-mailed statement.

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