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 (NOVOB)’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.”

To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Bloomberg reserves the right to remove comments but is under no obligation to do so, or to explain individual moderation decisions.

Please enable JavaScript to view the comments powered by Disqus.