麻豆传媒

WASHINGTON -- The FDA has approved dapagliflozin (Farxiga) for treatment of type 2 diabetes in adults, along with diet and exercise, the agency said .

The drug, supplied as a tablet, is a sodium glucose co-transporter 2 inhibitor "that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels," the statement said.

The approval comes with strings, however: drugmakers Bristol-Myers Squibb and AstraZeneca must conduct six post-market studies, which include a cardiovascular outcomes trial in patients with baseline cardiovascular disease risks, a bladder cancer risk trial, an animal study looking at drug-induced urinary flow and bladder tumor promotion, two trials on risks in pediatric patients, and an enhanced pharmacovigilance program to study liver abnormalities and pregnancy outcomes.

The drug was initially denied approval in 2012, when the FDA said the manufacturers had not provided sufficient information about its risks and benefits. The agency then OK'd a different sodium glucose co-transporter 2 inhibitor -- canagliflozin (Invokana) -- and making the Janssen Pharmaceuticals drug the first-in-class treatment. Janssen, too, was required to conduct several post-marketing studies.

In mid-December of last year, an FDA advisory panel voted 13-1 in favor of approving dapagliflozin, and 10-4 that the drug had an acceptable cardiovascular risk profile.

Safety and efficacy were established in 16 clinical trials of over 9,400 diabetes patients and showed patients had improvements in HbA1c with the drug.

Dapagliflozin should not be used by patients who have type 1 diabetes, increased ketones in their blood or urine, moderate or severe renal impairment, end-stage renal disease, or those on dialysis.

Nor should patients with active bladder cancer receive the drug.

Dapagliflozin has been associated with hypotension, particularly among older patients, those with impaired renal function, and those receiving diuretics.

Common adverse events include genital mycotic infection and urinary tract infection.

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