Posted by Michael Wonder on 05 Mar 2019
US FDA approves expanded Farxiga and Xigduo XR labels for use in patients with Type 2 diabetes and moderate renal impairment
27 February 2019 - Updated label confirms the well-established efficacy and safety profile for Farxiga and Xigduo XR.
AstraZeneca today announced that the US FDA has approved a label update for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) expanding use in patients with type 2 diabetes (T2D) and moderate renal impairment (chronic kidney disease with an estimated glomerular filtration rate [eGFR] of 45-59 mL/min/1.73 m2).
The updates were based on the results of DERIVE, a Phase 3 study of patients with inadequately controlled T2D (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.
