FDA Panel Rejects Experimental Diabetes Drug

A panel convened by the U.S. Food and Drug Administration voted yesterday against approval of the experimental diabetes drug, dapagliflozin, citing safety concerns associated with use of the drug, including increased risk for bladder and breast cancers.

The panel concluded that while the drug, which is the first-of-its-kind, had attractive features as a treatment for type-2 diabetes, there were simply too many unanswered questions regarding its safety. The drug is being developed by AstraZeneca and Bristol-Myers Squibb and is hoped to be the first to work to lower blood sugar by causing it to be excreted in urine. Drug manufacturers are in a heated race towards the creation of similar drugs, known as SGLT2 inhibitors.

In the United States, more than 25 million Americans suffer from diabetes, many of whom have type-2, otherwise known as adult onset diabetes, which is often associated with obesity. It is clear that the need for new drugs such as dapagliflozin would go a long way in treating those with the disease.

Ultimately, the panel’s committee members agreed that more research is needed in order to better assess the possible risks associated with use of the drug. Those panel members who voted against dapagliflozin want to see the results from additional studies of the drug, while those who voted in favor of dapagliflozin believe that studies could be conducted post-approval, as a means better observe the true effects of the drug as it is used.

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