FDA approves expanded indication for dapagliflozin in type 2 diabetes, kidney disease

The FDA on Wednesday approved a label update for the SGLT2 inhibitor dapagliflozin, expanding its use for patients with type 2 diabetes and moderate renal impairment, according to a press release form Astra Zeneca.

The expanded label indication is intended for both dapagliflozin (Farxiga) and dapagliflozin plus metformin extended-release (Xigduo XL) and lowers the estimated glomerular filtration rate threshold to 45 mL/min/1.73m², indicating moderate chronic kidney disease, from 60 mL/min/1.73m². Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic measures in adults with type 2 diabetes.

The updates were based on the results of the phase 3 DERIVE study, presented at the Endocrine Society annual meeting in March. In that study, patients with inadequately controlled type 2 diabetes and an eGFR between 45 mL/min/1.73 m2 and 59 mL/min/1.73 m2 assigned 10 mg dapagliflozin experienced a mean 0.35% greater HbA1c decrease over 24 weeks vs. similar patients assigned to placebo (P < .01). Compared with placebo, the researchers also observed greater reductions in body weight (mean, –1.43%; P < .001), fasting plasma glucose (mean, –16.59 mg/dL; P = .001), and systolic blood pressure (mean, –3.1 mm Hg; P < .05).

“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 of U.S. medical affairs and diabetes at AstraZeneca, said in the release.

Dapagliflozin is not recommended when the eGFR is less than 45 mL/min/1.73 m2 and remains contraindicated in patients with severe renal impairment, defined as an eGFR of less than 30 mL/min/1.73 m2, or end-stage renal disease or for patients on dialysis, according to the company. – by Regina Schaffer

Disclosure: McDermott reports he is vice president of U.S. medical affairs and diabetes at AstraZeneca.

The FDA on Wednesday approved a label update for the SGLT2 inhibitor dapagliflozin, expanding its use for patients with type 2 diabetes and moderate renal impairment, according to a press release form Astra Zeneca.

The expanded label indication is intended for both dapagliflozin (Farxiga) and dapagliflozin plus metformin extended-release (Xigduo XL) and lowers the estimated glomerular filtration rate threshold to 45 mL/min/1.73m², indicating moderate chronic kidney disease, from 60 mL/min/1.73m². Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic measures in adults with type 2 diabetes.

The updates were based on the results of the phase 3 DERIVE study, presented at the Endocrine Society annual meeting in March. In that study, patients with inadequately controlled type 2 diabetes and an eGFR between 45 mL/min/1.73 m2 and 59 mL/min/1.73 m2 assigned 10 mg dapagliflozin experienced a mean 0.35% greater HbA1c decrease over 24 weeks vs. similar patients assigned to placebo (P < .01). Compared with placebo, the researchers also observed greater reductions in body weight (mean, –1.43%; P < .001), fasting plasma glucose (mean, –16.59 mg/dL; P = .001), and systolic blood pressure (mean, –3.1 mm Hg; P < .05).

“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 of U.S. medical affairs and diabetes at AstraZeneca, said in the release.

Dapagliflozin is not recommended when the eGFR is less than 45 mL/min/1.73 m2 and remains contraindicated in patients with severe renal impairment, defined as an eGFR of less than 30 mL/min/1.73 m2, or end-stage renal disease or for patients on dialysis, according to the company. – by Regina Schaffer

Disclosure: McDermott reports he is vice president of U.S. medical affairs and diabetes at AstraZeneca.