AstraZeneca has secured the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for its Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
Forxiga is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. It has shown efficacy in preventing and delaying cardiorenal disease, while protecting the organs.
The drug was already approved in the US and the European Union for the treatment of CKD in adults with and without T2D, and is currently under review in other countries.
CKD is a condition characterised by declined kidney function, and often associated with an elevated risk of heart disease or stroke, or the need for dialysis or kidney transplant.
In 2013, AstraZeneca’s Japan subsidiary AstraZeneca K.K. (AZKK) has reached an agreement with Ono Pharmaceutical to distribute and market Forxiga in Japan, along with co-promote the drug together with AZKK.
Both companies have been co-promoting the drug for the treatment of T2D, T1D and chronic HF, and will co-promote for the treatment of CKD.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “This approval is an important step towards realising our ambition of improving outcomes for patients with chronic kidney disease.
“While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.”
The regulatory approval in Japan was based on positive results from the DAPA-CKD Phase 3 trial, following an MHLW Priority Review designation granted earlier this year.
DAPA-CKD is a multi-centre, randomised, double-blinded Phase 3 trial, designed to evaluate the efficacy of Forxiga compared with placebo, in 4,304 participants.
In the study, Forxiga 10mg is administered once daily, in addition to standard of care (SoC) treatment using angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.
Forxiga reduced the relative risk of worsening of renal function, the onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39%, the primary composite endpoint.
Also, the drug reduced the relative risk of death from any cause by 31%, with consistent safety and tolerability with the well-established safety profile of the medicine.
Time to the first occurrence of renal composite, composite of CV death or hospitalisation for HF (hHF), and death from any cause include the secondary endpoints.
DAPA-CKD Phase 3 trial Japan national coordinator Naoki Kashihara said: “DAPA-CKD is the landmark trial that demonstrated unprecedented risk reduction for chronic kidney disease patients with and without type-2 diabetes. This transformational milestone will bring great hope to many patients with chronic kidney disease in Japan.”
