AstraZeneca has secured expanded approval from the US Food and Drug Administration (FDA) for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin HCl extended-release) to treat type 2 diabetes (T2D) and moderate renal impairment.
The expanded Farxiga and Xigduo XR labels have been approved to treat patients with T2D and moderate renal impairment, which is a chronic kidney disease with an estimated glomerular filtration rate [eGFR] of 45-59 mL/min/1.73 m².
Farxiga is designated as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes mellitus, while Xigduo is designated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
The updated labels reduce the eGFR threshold to 45 mL/min/1.73 m² from 60 mL/min/1.73 m², enabling to expand the application of the treatment to more population.
The updates have been based on the results of Derive phase 3 study, which included patients with inadequately controlled T2D and an eGFR of 45 to 59 mL/min/1.73m² who secured either Farxiga(dapagliflozin 10 mg) or placebo over 24 weeks.
According to the company, Farxiga (dapagliflozin 10mg) provided statistically significant reductions in HbA1c compared against placebo.
The safety profile following treatment duration of 24 weeks has been similar to that observed n the overall Farxiga clinical trial program, said AstraZeneca.
As per the Centers for Disease Control and Prevention, around 30.3 million people in the US are suffering with diabetes, while T2D accounts for 90% to 95% of all diabetes cases.
AstraZeneca diabetes US medical affairs vice president Dr Jim McDermott said: “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.”
AstraZeneca is engaged in the discovery, development and commercialization of prescription medicines to treat diseases in three main therapy areas, including oncology, cardiovascular, renal and metabolism and respiratory.