China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adult patients who are at risk of progression with and without type-2 diabetes (T2D).
Forxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that is administered orally once every day.
It has shown efficacy in preventing and delaying cardiorenal disease, while protecting the organs.
The therapy is approved for reducing the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation due to heart failure (hHF) in CKD adult patients with and without T2D.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “In addition to AstraZeneca’s commitment to drive increased awareness, prevention and earlier diagnoses, this approval marks another important step forward in our ambition to stop, reverse and ultimately cure chronic kidney disease globally.
“We are thrilled at the opportunity to bring Forxiga to millions of patients across the country and improve patient outcomes.”
The regulatory approval in China was based on the positive data obtained from the DAPA-CKD Phase III trial conducted in 4,304 participants.
The double-blinded, multi-centre, randomised, international DAPA-CKD Phase III trial evaluated Forxiga’s efficacy compared with placebo, in CKD patients with Stage 2-4 and elevated urinary albumin excretion, with and without T2D.
In the study, Forxiga 10mg was administered once a day, in addition to standard of care (SoC) treatment using angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.
The findings showed that the therapy reduced the relative risk of renal function worsening, onset of ESKD, or CV risk or renal death by 39%, as against placebo. This is the trial’s primary composite endpoint.
Additionally, Forxiga reduced relative risk of death from any cause by 31% versus placebo, with consistent safety and tolerability observed with the well-established safety profile of the medicine.