Dapagliflozin Receives FDA's Fast Track for Chronic Kidney Disease
The oral therapy is indicated to act as both a monotherapy and a combination therapy to improve glycemic control. It is also indicated to prevent cardiovascular and renal death in patients with CKD.
Officials from the FDA have approved a Fast Track designation for the development of AstraZeneca Pharmaceuticals’ dapagliflozin (Farxiga), to help delay the progression of complications involving chronic kidney disease (CKD).
The oral therapy is indicated to act as both a monotherapy and a combination therapy to improve glycemic control. It is also indicated to prevent cardiovascular and renal death in patients with CKD.
The overall effect of Farxiga is currently being evaluated through the Phase III DAPA-CKD clinical trial. Participants include patients with CKD, with and without T2D, versus placebo on top of standard care.
CKD is associated with heart failure, chronic fluid overload, and therapy-resistant hypertension, and affects an estimated 200 million adults globally.
The Fast Track program was established by the FDA to help accelerate the creation and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.
Reference
FDA grants fast track designation for Farxiga in chronic kidney disease [news release]. August 27, 2019: AstraZeneca website. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/fda-grants-fast-track-designation-for-farxiga-in-chronic-kidney-disease-27082019.html. Accessed August 27, 2019.
