New diabetes drug refused approval in the US

Thu, 19 Jan 2012
The first diabetes drug in a new class of experimental treatments has failed to receive regulatory approval in the United States. The Food and Drug Administration (FDA) has asked to see more data on the safety of the treatment, developed by pharma giants AstraZeneca and Bristol-Myers Squibb, and it could face further clinical trials.

The drug, dapagliflozin, which is aimed at patients with type 2 diabetes, is part of a new class of treatments called SGLT2-inhibitors, which help patients to excrete excess blood sugar in their urine. AstraZeneca, which is based in London, and Bristol-Myers, based in New York, have said they are committed to continuing to work with the drug to make safe.

Dapagliflozin was found by the FDA to be effective in lowering blood sugar levels, but there were concerns about the risks of bladder and breast cancer, as well as possible liver risks.

There were nine cases of bladder cancer reported by male patients in clinical trials for dapagliflozin, as compared to just the one case for patients who took a placebo, while breast cancer was also found in nine patients who took the drug, as compared with one in the placebo group.

It is thought the failure of the drugs to gain approval for sale is part of the greater attention being paid to new diabetes treatments following the controversy over Avandia, being linked to heart attacks.

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