FDA Approves Expanded Indication for dapagliflozin in Type 2 Diabetes, Kidney Disease

Published on
By : dLife Editors

The U.S. Food and Drug Administration (FDA) has approved a label update for AstraZeneca’s FARXIGA® (dapagliflozin) and XIGDUO® XR (dapagliflozin and metformin HCl extended-release) expanding use in patients with Type 2 diabetes and moderate renal impairment.

FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes when treatment with both dapagliflozin and metformin is appropriate.

According to a company press release, the updated labels lower the eGFR threshold, expanding the potential population of patients with Type 2 diabetes and impaired renal function who may benefit from the medicine.

FARXIGA and XIGDUO XR are not recommended when the eGFR is less than 45 mL/min/1.73 m2 and remains contraindicated in patients with severe renal impairment, end-stage renal disease, or in patients on dialysis.

The updates were based on the results of DERIVE, a Phase 3 study of patients with inadequately controlled Type 2 diabetes (HbA1c 7.0%-11.0%) and an eGFR of 45 to 59 mL/min/1.73 m2 who received either FARXIGA (dapagliflozin 10 mg) or placebo over 24 weeks.

At week 24, FARXIGA (dapagliflozin 10 mg) provided statistically significant reductions in HbA1c compared with placebo. The safety profile following a treatment duration of 24 weeks was similar to that seen in the overall FARXIGA (dapagliflozin) clinical trial program.

“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 an impaired renal function to potentially benefit from these important treatment options,” said Dr. Jim McDermott, vice president, U.S. Medical Affairs, Diabetes at AstraZeneca.

According to the Centers for Disease Control and Prevention, 30.3 million people in the U.S. have diabetes, and Type 2 diabetes accounts for 90% to 95% of all diabetes cases.

Source:

  1. US FDA Approves Expanded FARXIGA and XIGDUO XR Labels for Use in Patients with Type 2 Diabetes and Moderate Renal Impairment. (2019, Feb. 27) Business Wire. Retrieved: https://www.businesswire.com/news/home/20190227005113/en