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Dapagliflozin Diabetes Drug Rejected By FDA Advisors
Thu, 21 Jul 2011
A new type of diabetes medication from AstraZeneca and Bristol-Myers Squibb has been rejected by US health regulator, the Food and Drug Administration (FDA), over concerns about liver and cancer risks.

An FDA advisory panel voted 9-6 against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes.

Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy - especially for elderly patients.

The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the experimental drug by October 28.

Dapagliflozin is a once-daily type 2 diabetes medication designed to allow excess sugar to be excreted with urine rather than being absorbed into the bloodstream through the kidneys.

Clinical trails showed that the drug was effective at controlling blood glucose levels in type 2 diabetics and helping patients lose weight.

However, five patients treated with the pill developed liver damage, ten participants developed bladder cancer and nine developed breast cancer .
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