New Type 2 Diabetes Drug Farxiga Approved by FDA

First Posted: Jan 09, 2014 08:04 AM EST

The U.S. Food and Drug Administration has announced the release of a novel drug Farxiga to treat adults with type 2 diabetes.

In a latest announcement FDA disclosed the release of a drug dapaglifozin. It is marketed under the name Farxiga and it can improve glycemic control along with proper diet and exercise, in patients with type-2 diabetes.

The newly approved Farxiga tablet, marketed by Bristol Meyers Squibb and AstraZeneca, is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. The drug obstructs the re-absorption of glucose by the kidney. The drug also increases the glucose excretion and reduces the levels of blood glucose.  

The once-a-day tablet received a nod from the agency after its safety and effectiveness was tested through 16 clinical trials that involved nearly 9,400 patients with type-2 diabetes. The approval of the drug comes after canagliflozin was approved last March, the first drug in the class of medication that got a clearance from FDA.

"Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The drug was tested alone and in combination with other diabetes therapies that include metfomin, pioglitazone, glimpiride, sitagliptin and insulin.

The drug cannot be used to treat people with type 1 diabetes, patients on dialysis, those who have high levels of ketones in blood and urine and those with moderate-severe renal impairment. Since the rate of bladder cancer soared during the trial among those taking Farxiga, the drug is not recommended for those with active bladder cancer.  At the end of the trial an improvement in HbA1c was noticed, which is a measure of blood sugar control.

The drug might cause dehydration, dizziness/fainting as a result of hypotension and drop in renal function. Some of the common side effects noticed were genital mycotic (fungal) infections and urinary tract infections. FDA has also asked for six post-marketing trials.

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