Farxiga FDA-approved for type 2 diabetes

Farxiga, a new diabetes drug, was approved by the U.S. Food and Drug Administration (FDA) last week.

The medication comes in tablets that work to improve glycemic control when paired with diet and exercise, a press release on the announcement stated.

“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.

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Clinical trial results

In the past, Farxiga has been studied in combination with other type 2 diabetes drugs like metformin, pioglitazone, sitagliptin and insulin. To determine the drug's safety, 16 clinical trials were conducted with more than 9,400 patients with type 2 diabetes.

The trials showed the drug was effective at improving HbA1c, a measure of blood sugar control. Yet, because Farxiga has been linked to a higher incidence of bladder cancer, it is not recommended for people with active bladder cancer or a history of bladder cancer.

Common side effects

Some of the common side effects experienced by Farxiga users were gential mycotic (fungal) infections and urinary tract infections.

The FDA is calling for post-market research on the drug, including studies that will assess the drug's impact on cardiovascular outcomes, bladder cancer, liver abnormalities and pregnancy.

Source: FDA

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