AstraZeneca’s Forxiga (dapagliflozin), a 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 (T2D).
The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. The decision follows the Priority Review designation granted by the MHLW earlier this year.
CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.2-4 The condition affects 840 million people worldwide.5 However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.4 Forxiga is the first ever approved medicine for the treatment of the disease in Japan.
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.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.”
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