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FDA approves dapagliflozin for type 2 diabetes
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The FDA approved dapagliflozin (Farxiga, Bristol-Meyers Squibb and AstraZeneca) today, according to a press release. This is the second sodium-glucose co-transporter 2 inhibitor approved for the treatment of type 2 diabetes.
“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,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The drug is believed to work by blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels.
On December 12, 2013, 2 years after advising against approval, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 in favor of the updated cardiovascular risk profile of dapagliflozin. The committee also voted 13-1 in favor of the agent as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Due to safety concerns, the drug is not recommended for patients with active bladder cancer. In addition, elderly patients with impaired renal function, and patients on diuretics to treat other conditions appear to be more susceptible to renal failure risk, according to the press release.
Six post-marketing studies are being required by the FDA, including:
- Cardiovascular outcomes trial (CVOT) to evaluate the CV risk of dapagliflozin in patients with high baseline risk for CVD;
- A double-blind, randomized, controlled evaluation of bladder cancer risk in patients enrolled in the CVOT;
- An animal study investigating dapagliflozin-induced urinary flow/rate and composition changes on bladder tumor promotion;
- Two clinical trials to determine the pharmacokinetics, efficacy, and safety in pediatric patients; and
- An enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
The most common adverse events associated with the use of dapagliflozin include genital mycotic infections and urinary tract infections, according to data.
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