FDA Sides With EMA on Incretin Diabetes Drugs

Megan Brooks

August 01, 2013

The US Food and Drug Administration (FDA) agrees with the European Medicines Agency (EMA) that available data do not confirm recent concerns over an increased risk for pancreatic side effects with glucagonlike peptide-1 (GLP-1)-based diabetes therapies, a spokeswoman for the FDA told Medscape Medical News today.

The EMA announced their conclusions, based on the evidence to date, on July 26, as reported by Medscape Medical News.

"There is no change in evidence regarding the risks," concluded the EMA's Committee for Medicinal Products for Human Use (CHMP), which has finalized a review of GLP-1-based diabetes therapies, also known as incretins. These comprise 2 classes of medicines: GLP-1 agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors.

Lisa Kubaska, from the FDA's Center for Drug Evaluation and Research (CDER), told Medscape Medical News today, the FDA "had conversations with EMA and was aware of their analyses regarding the potential pancreatic effects of GLP-1 based therapies. Our general view is that their conclusions are consistent with our current understanding of the data."

Concerns over pancreatic effects of the incretin class of diabetes medications, including pancreatic cancer, surfaced following a study published March 22, 2013, in Diabetes , which found abnormal changes, including precancerous lesions, in the pancreases of 8 organ donors talking GLP-1-based drugs compared with patients taking other antidiabetic drugs.

Following the publication of this study, the BMJ on June 10 published an in-depth investigation of the issue, concluding that pancreatitis and pancreatic cancer associated with incretin mimetic therapies has been downplayed by the pharmaceutical industry.

On June 14, 2013, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) gathered experts to discuss the issue at a 2-day meeting. They concluded that there is currently little evidence for an increased risk for pancreatic cancer associated with use of GLP-1-based therapies.

"FDA's review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs. Additionally, there is an ongoing epidemiological study," Kubaska said.

For now, "FDA believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time," she told Medscape Medical News.

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