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EMA launches diabetes drugs safety review

Will investigate pancreatitis risks in two major drug classes

European Medicines Agency (EMA) - logoEuropean regulators are to investigate the possibility that diabetes drugs like Novo Nordisk's Victoza and Merck & Co's Januvia increase the risk of pancreatitis.

News of the safety review comes one week after the EMA's US counterpart began its own investigation into the drugs.

Both regulators were spurred into action by research published in Diabetes suggesting type 2 diabetics receiving GLP-1-based medicines could face an increased risk of pancreatitis as well as pre-cancerous cellular changes called pancreatic duct metaplasia. 

The EMA will now look at GLP-1-based therapies, or incretin mimetics, in a review that will cover glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors.

Both classes of drugs have been big sellers for pharma and, in addition to Victoza and Januvia, other brands caught up in the review include Sanofi's new Lyxumia, BMS and AstraZeneca's Onglyza, and Boehringer and Lilly's Trajenta.

All these drugs act like hormones called incretins (hormones produced in the intestine) by increasing the amount of insulin released by the pancreas in response to food. 

The Diabetes findings were based on examination of a small number of pancreatic tissue samples obtained from organ donors with and without diabetes mellitus, who died due to causes other than diabetes.

The EMA's Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) are currently investigating the information provided by the researchers to determine the need for possible further regulatory action.

The EMA said there was no need for patients to stop taking their medicines and that healthcare professionals could continue to prescribe these medicines in accordance with the product information.

But the regulator said it has not reached any conclusions on its investigation and has not changed its recommendations on the use of the drugs – echoing the FDA's response.

Nevertheless, both regulators were already aware that effects on the pancreas could be a possible risk for GLP-1-based medicines.

While warnings for patients and healthcare professionals are included in the product information for all these medicines the new investigations could see these tightened up. 

27th March 2013

From: Sales



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