EMA: no cancer risk from GLP-1s
pharmafile | July 29, 2013 | News story | Research and Development, Sales and Marketing | Cancer, EMA, GLP-1s
One of the European Medicines Agency’s key advisory groups has decided that concerns over an increased cancer risk with some diabetes drugs are unfounded.
The CHMP’s review of GLP-1-based diabetes therapies has concluded that available information does not “confirm recent concerns over an increased pancreatic cancer risk”.
The term comprises two classes of medicines: glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors.
A long list of such drugs is approved in the EU, including Lilly’s Byetta/Bydureon (exenatide), Novo Nordisk’s Victoza (liraglutide), Sanofi’s Lyxumia (lixisenatide), Merck’s Januvia (sitagliptin), AstraZeneca’s Onglyza (saxagliptin) and Boehringer Ingelheim’s Trajenta (linagliptin).
The EMA review was undertaken after a study by a group of independent academics suggested problems with GLP-1-based drugs in patients with type 2 diabetes.
Specifically, the study said they led to an increased risk of pancreatitis (inflammation of the pancreas) and cellular changes called pancreatic-duct metaplasia in this patient group.
The review was based on a small number of pancreatic tissue samples obtained from organ donors – not all of whom had diabetes and who all died due to causes other than diabetes.
The CHMP found that this study was limited and contained ‘potential sources of bias’, particularly in terms of differences between the studied groups when it came to age, gender, disease duration and treatments.
These issues “preclude a meaningful interpretation of the results”, the CHMP decided, although the group also considered all other available non-clinical and clinical data before reaching its decision.
That is not to say, however, that there are no worries at all over GLP-1-based treatments in diabetes patients: although trial data does not indicate an increased risk of pancreatic cancer with these medicines, the number of events is too small to draw final conclusions, the CHMP admitted.
It is true that some cases of pancreatitis have been reported and all these medicines already carry warnings in their product information, and several studies into the risks are either planned or ongoing.
First results from two large, European Commission-funded independent investigations, started in 2011, are expected to be seen in spring 2014.
The EMA published updated guidance on diabetes drugs last year after a number came under scrutiny because of their side effects, notably on the cardiovascular system and increasing the risk of certain cancers.
GSK’s Avandia was removed completely from Europe in 2010, while Takeda’s Actos was given further safety warnings after it was found to increase the risk of bladder cancer.
Adam Hill
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