FDA/CDC

FDA approves label extension for dapagliflozin


 

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m2 from the current60 mL/min per 1.73 m2.

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The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m2 who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

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