EMA Says No Pancreatic Cancer Risk with Diabetes Drugs

EMA Says No Pancreatic Cancer Risk with Diabetes Drugs

July 29th, 2013 // 1:26 pm @

Latest FDA and cGMP Compliance News

The European Medicines Agency has decided that there is not any evidence to confirm recent theories that commonly used diabetes drugs, called GLP-1 inhibitors, has any link to pancreatic cancer.

This review was done in response to a controversy about a study that was published in the magazine Diabetes a few months back. The study found that in humans, the drugs cause cell damage and proliferation, and showed a potential for changing into cancer. The study examined the pancreas of 20 deceased organ donors who had type 2 diabetes.

However, the Committee for Medicinal Products for Human Use at the EMA decided that the study had several potential bias sources and several methodological limitations. Most importantly, there were differences between the groups studied regarding gender, age, treatments and disease duration, which makes it difficult to interpret the results, the EMA said.

The Committee stated that the data from clinical studies do not show a higher risk with these drugs. The number of events in the studies are not large enough to draw conclusions. Due to the action mechanism, there are some uncertainties regarding the long term effects of the drugs on the pancreas, and more data collection is necessary.

The drugs imitate a hormone known as GLP-1 to stimulate the production of insulin in the body. They include Januvia by Merck; Onglyza by Bristol Myers Squibb; Byetta by Bristol Myers Squibb; and Tradjenta by Eli Lilly.

We do not know if this is the final word on this subject. In June, the US NIH had a two day conference to look at the safety of these drugs, and the event did not turn up anything new. However, FDA has started its review this year and no decision has been made yet.

The American Diabetes Association has asked for pharmaceutical firms to release data at the patient level for a fully independent review. Still, the ADA is saying currently that there is not enough information at this time to change treatment options for this form of cancer.

We can’t say if the ADA will change course. According to Robert Ratner, ADA’s chief medical officer, the ADA is going to keep working with industry to get better clarification of risks and benefits of incretin therapy.

It seems that for now, drug makers and investors should feel a sense of relief. FDA and EMA are going to keep watching the drugs for signs of adverse events related to pancreatic cancer, but the EMA press release and the NIH meeting should provide some reassurance to the public for now.

EMA notes that there are two large studies under way since 2011 to better study the cancer risks of these drugss. The first results of the studies are expected in mid 2014.

Other studies have added to concerns, however. A study in JAMA Internal Medicine in March looked at the insurance records of 2600 diabetics from 2005-8, and found that patients who had pancreatitis had two times the risk to have been treated with Byetta or Januvia, than a control group of diabetics who did not have pancreatitis.

 

 


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