FDA Approves New Drug For Patients With Type 2 Diabetes

On Jan. 8 the U.S. Food and Drug Administration (FDA) approved Farxiga (dapaglifozin) tablets, which works to treat type two diabetes in adults by “block[ing] the reabsorption of glucose by the kidney, increase[ing] glucose excretion, and lower[ing] blood glucose levels” according to the announcement.

Although the drug was originally denied approval in 2012 due to insufficient information regarding the risks and benefits, the FDA has granted Bristol-Myers Squibb and AstraZeneca approval of the drug with the exception that they conduct six post-market studies.

The post-market study requirements listed include a cardiovascular outcomes trial in patients with baseline cardiovascular disease risks, a trial on bladder cancer risk, an animal study that evaluates the drug-induced urinary flow and bladder tumor promotion, two clinical trials that establish the risks in pediatric patients, and an enhanced pharmacovigilance program that monitors liver abnormalities and pregnancy outcomes.

Prior clinical studies of the drug suggest that the most common side effects in patients on Farxiga were genital mycotic infection and urinary tract infection.

Keywords: United States Food and Drug Administration, Diabetes Mellitus, Type 2, Pharmacovigilance, Risk Assessment, Tablets, Glucose

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