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EMA: no new safety concerns with GLP-1 diabetes drugs

CHMP takes issue with study that linked the treatments to serious side effects

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The EMA has drawn to a close its investigation into the safety of GLP-1 based treatments for diabetes, concluding there are no new safety concerns with the treatments.

The European regulator launched its safety review of the GLP-1 class, which includes prominent brands like Novo Nordisk's Victoza (liraglutide) and Bristol-Myers Squibb's Byetta (exanatide), in March.

It acted after research published in the journal Diabetes linked the drug class to an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia.

Wrapping up its review, the EMA said that “presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines”.

During the investigation it was reported that data linking the drugs and cancer had been withheld, however the EMA concluded “GLP-1 based therapies are effective treatments for type-2 diabetes and add to the available medication options”.

Releasing their findings, EMA advisors at the CHMP took issue with the Diabetes study, which they said had a number of methodological limitations and potential sources of bias.

“Most importantly [these were] differences between the studied groups with respect to age, gender, disease duration and treatments, which preclude a meaningful interpretation of the results,” they said.

After a review of all available non-clinical and clinical data the CHMP decided there was no change in the evidence for the risks of pancreatic adverse events associated with the use of GLP-1 based therapies.

The GLP-1 based therapy class includes both glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors.

All these medicines already carry pancreatitis warnings in their product information, and a small number of cases of pancreatitis have been reported in clinical trials and a significant number of spontaneous reports cases observed.

While the CHMP said these “need to be interpreted cautiously”, more may be known next year.

Two large independent studies have been under way since 2011 to study the risk profile of diabetes treatments in general, and more specifically their risk profile in relation to the pancreas.

Funded by the European Commission, the first results from these studies are expected in the spring of 2014.

Meanwhile, an investigation by US regulator the FDA into the safety of the GLP-1 class, which began one week before the EMA's review, is still on-going.

29th July 2013

From: Regulatory

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