China’s NMPA approves AstraZeneca’s Forxiga to treat chronic kidney disease

Forxiga (dapagliflozin) from AstraZeneca has been authorized by China's National Medical Products Administration (NMPA) to treat adult patients with chronic kidney disease (CKD) who are at risk of progression both with and without type 2 diabetes.

Forxiga is a daily oral dose of sodium-glucose cotransporter 2 (SGLT2) inhibitor. While safeguarding the organs, it has demonstrated effectiveness in stopping and delaying cardiorenal illness.

In CKD adult patients with and without T2D, the medication is authorized for lowering the risk of persistent estimated glomerular filtration rate (eGFR) decrease, end-stage kidney disease (ESKD), cardiovascular (CV) mortality, and hospitalization due to heart failure (hHF).

Mene Pangalos, executive vice-president of AstraZeneca BioPharmaceuticals R&D, stated: "This approval marks another important step forward in our ambition to stop, reverse, and ultimately cure chronic kidney disease throughout the world, in addition to AstraZeneca's commitment to drive increased awareness, prevention, and earlier diagnoses.

Mene Pangalos, executive vice-president of AstraZeneca BioPharmaceuticals

Based on the encouraging results from the 4,304 participant DAPA-CKD Phase III study, the regulatory approval in China was granted.

In Chronic kidney disease patients with Stages 2-4 and high urine albumin excretion, both with and without Type 2 diabetes, the effectiveness of Forxiga was compared to placebo in the double-blinded, multi-center, randomised, worldwide DAPA-CKD Phase III study.