By Fineline Cube UK pharma giant AstraZeneca (AZ, NASDAQ: AZN) announced a new approval for Farxiga (dapagliflozin), its sodium-glucose cotransporter 2 (SGLT2) inhibitor, in China. The drug is now cleared to reduce risks of kidney function decline, end-stage kidney disease, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease (CKD), marking the first SGLT2 inhibitor approved for CKD in the country.
Study Results
The approval follows the Phase III DAPA-CKD trial, which showed Farxiga cut the relative risk of worsening renal function or death by 39% (absolute risk reduction = 5.3%, P < 0.0001) in stage 2-4 CKD patients with elevated urinary albumin. The drug also reduced all-cause death risk by 31% (ARR = 2.1%, P = 0.0035) vs. placebo. Safety data aligned with prior trials.
Regulatory and Market History
Farxiga, first approved in China for type 2 diabetes in 2017, was greenlit for heart failure with reduced ejection fraction (HFrEF) in 2021. It entered China’s National Reimbursement Drug List (NRDL) in 2019 and renewed in 2021. Generic versions by Winsunny Pharma and Lukang Pharma were approved in October 2021.-Fineline Info & Tech