EMA follows FDA lead, launching investigation on pancreatic risks with GLP-1-based type 2 diabetes drugs

The European Medicines Agency says it is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with so-called GLP-1-based therapies (glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors).

Drugs in the incretin mimetic class include a number of blockbuster drugs, such as: Eli Lilly's (NYSE: LLY) Byetta, Bydureon (exenatide), which are in the process of being acquired by Bristol-Myers Squibb partnered with AstraZeneca; Novo Nordisk’s (NOV: N) Victoza (liraglutide); Merck & Co’s (NYSE: MRK) sitagliptin brands Januvia, Janumet, Janumet XR, Juvisync; saxagliptin (Onglyza, Kombiglyze XR, also from B-MS); and linagliptin (Tradjenta, Jentadueto from Eli Lilly and Boehringer Ingelheim).

The EMA move follows an announcement earlier this month by the US Food and Drug Administration, revealing it is evaluating unpublished new findings that suggest an increased risk of pancreatitis in this group of diabetes treatments (The Pharma Letter March 15).