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FDA Advisory Panel Recommends Approval of New Diabetes Drug — Physician’s First Watch

Medical News |
December 16, 2013

FDA Advisory Panel Recommends Approval of New Diabetes Drug

By Amy Orciari Herman

FDA advisers voted 13 to 1 on Thursday to recommend approval of the diabetes drug dapagliflozin, Reuters reports. The drug's mechanism of action — inhibition of the sodium-glucose transporter in the kidneys — leads to reduced renal glucose reabsorption and increased glucose excretion.

The advisory panel also voted 10 to 4 that dapagliflozin has a favorable cardiovascular risk profile. A potential excess of bladder cancers did raise a red flag for some advisers, with one saying the FDA should require the potential risk to be listed on the label. The same adviser, according to Reuters, said he "really" likes the drug, pointing out that it lowers blood pressure and enables weight loss.

In 2012, the FDA rejected dapagliflozin, citing concerns about potential heart and cancer risks. Last week's advisory panel vote, however, was based on results from new studies and longer-term data from prior trials.

Earlier this year, the FDA approved another drug with the same mechanism of action, called canagliflozin.

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