FDA grants fast track designation to Farxiga for CKD
The FDA granted fast track designation for the development of Farxiga for patients with chronic kidney disease, according to a press release from AstraZeneca.
Farxiga (dapagliflozin), meant to delay the progression of kidney failure and to prevent cardiovascular and renal mortality, is being evaluated in phase 3 of the DAPA-CKD clinical trial in patients with and those without type 2 diabetes.
“The FDA’s fast track designation for the development of Farxiga is an important step to address unmet treatment needs in patients living with CKD, which affects an estimated 37 million people in the U.S.,” Kiersten Combs, vice president of U.S. cardiovascular and metabolic disease at AstraZeneca, told Healio/Nephrology. “At AstraZeneca, we are committed to advancing the understanding of cardio-renal-metabolic diseases and delivering innovative solutions to identify a potential portfolio of treatments that can help transform care.”
For patients with type 2 diabetes, the drug is intended to serve as an addition to diet and exercise to improve glycemic control, according to the release.
“The current approach includes looking at the full treatment scope of CKD and its associated complications,” Combs said. “We will work closely with the FDA to explore the potential for Farxiga to improve outcomes for patients with CKD. Through our continued advancements in science across our entire cardio-renal portfolio, AstraZeneca has the opportunity to positively impact millions of patients living with CKD and its associated comorbidities.”
Farxiga should not be used in patients with type 1 diabetes or patients with eGFR less than 30 mL/min/1.73m2.