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Fresh scrutiny for new diabetes drugs

Published on 15/09/11 at 10:18am

Merck’s Januvia and Lilly’s Byetta face renewed safety questions this week as the European Association for the Study of Diabetes debates their links with cancer.

A recent data review found a six-fold increase in the chances of patients receiving Lilly/Amylin’s GLP-1 analogue Byetta or Merck & Co's DDP-4 inhibitor Januvia (which also raises levels of GLP-1) of developing pancreatitis, which also significantly increases their risk of pancreatic cancer.

The companies denied the review proved an increased cancer risk and said their drugs were safe.

The study did not look at Novo Nordisk’s new injectable GLP-1 analogue Victoza, but it too will now come under fresh scrutiny from the European Association for the Study of Diabetes.

Novo’s chief science officer Mads Thomsen told Bloomberg that Victoza has a “very benign side effect profile”.

“The more evidence we gather, the more we are seeing a level of pancreatitis that is well within the expected range for people who have type II diabetes,” he added.

Earlier this week Novo released new data showing that earlier use of Victoza, which is currently licenced for patients at a later stage in their disease, could significantly help diabetics keep their blood sugar levels down.

Balancing risk with new treatments for diabetes

Diabetes has become a global epidemic with 366 million cases of the disease now registered across the world.

It is a highly lucrative market for pharma but consistent safety concerns, including increased cancer and cardiovascular risks, have raised questions over the future of current and new treatments.

In June both France and Germany pulled Takeda’s diabetes drug Actos after new data showed an increased risk of bladder cancer in patients taking the treatment on a long-term basis.

Last year GlaxoSmithKline’s diabetes drug Avandia was pulled from the European market and heavily restricted in the US after its was shown to increase the risk of cardiac events in patients.

Ben Adams

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