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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

New Chemicals Have Risks in Treament of Type 2 Diabetes Mellitus

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Watchdog group Public Citizen is urging the U.S. Food and Drug Administration (FDA) not to approve dapagliflozin because it is not more effect than canagliflozin, a similar drug approved by the agency in March 2013. The drug, which is a member of a new chemical class of drugs intended to treat type 2 diabetes, poses health concerns including the risk of bladder cancer and liver toxicity.

Dapagliflozin shows no evidence of any improved clinical outcomes in comparison to metformin, an older drug. The question at hand, according to the agency, is that, “… The [surrogate] efficacy of dapagliflozin needs to be balanced against safety signals identified in clinical trials.” As it stands now, there is a vote nine to six against approval.

In clinical trials, a surrogate endpoint (or marker) is a measure of effect of a certain treatment that may correlate with a real clinical endpoint, but doesn’t necessarily have a guaranteed relationship.

Dapagliflozin works by inhibiting sodium glucose cotransporter 2 (SGLT2) and blocking reabsorption of glucose in the kidney, leading to an increase in urinary glucose excretion and lowering of both plasma glucose levels and body weight.

Dapagliflozin is the second SGLT2 inhibitor to be licensed in the United States.