AstraZeneca PLC (LSE:AZN) (LSE:AZN) said Forxiga (dapagliflozin), its sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes.
The approval by Japan's Ministry of Health, Labour and Welfare follows positive results from the DAPA-CKD Phase III trial and comes after the Ministry granted Forxiga 'Priority Review' status earlier this year.
CKD is a serious condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. The condition affects 840mln people worldwide, but diagnosis rates remain low and up to 90% of patients are unaware they have the disease, AstraZeneca said in a statement. Forxiga is the first ever approved medicine for the treatment of the disease in Japan, where more than 13mln people suffer from CKD, it added.
The DAPA-CKD Phase III trial showed that Forxiga, on top of standard-of-care treatment, reduced the relative risk of worsening of renal function, onset of end-stage kidney disease or risk of cardiovascular or renal death by 39%, the primary composite endpoint, compared to placebo. Forxiga also significantly reduced the relative risk of death from any cause by 31%.
The national coordinator of the DAPA-CKD Phase III trial in Japan, Naoki Kashihara, President of the Japanese Society of Nephrology, 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."
Forxiga was recently approved in the US and the European Union for the treatment of CKD in adults with and without T2D and is under review in several other countries.
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