FDA Approves New Drug for Treating Type 2 Diabetes
On January 8, 2014, the FDA approved Farxiga (dapaglifozin) tablets to help improve glycemic control in adults with type 2 diabetes. The drug is a sodium-glucose co-transporter 2 inhibitor that works by blocking the reabsorption of glucose by the kidneys, increasing glucose exertion, and lowering blood glucose levels, when combined with diet and exercise. The safety and efficacy of Farxiga were demonstrated in 16 clinical trials involving more than 9400 adults with type 2 diabetes, nearly one-quarter of whom were above the age of 65 years.
The recommended starting dosage of Farxiga is 5 mg once daily, taken in the morning, with or without food. The dose can be increased to 10 mg once daily for patients who require additional glycemic control. The drug is not indicated for patients with type 1 diabetes or diabetic ketoacidosis, patients with moderate to severe renal impairment or end-stage renal disease, patients with active bladder cancer, and patients on dialysis. The FDA is requiring six post-marketing studies, including a cardiovascular outcomes trial.
The most common side effects associated with taking Farxiga include genital fungal infections and urinary tract infections. In patients aged 65 years and older, a higher proportion of patients treated with Farxiga had adverse reactions related to volume depletion and renal impairment or failure compared with patients treated with placebo. Farxiga is marketed by Bristol-Meyers Squibb and AstraZeneca. Access the prescribing information at https://packageinserts.bms.com/pi/pi_farxiga.pdf.
