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AstraZeneca’s Forxiga approved in Japan for the treatment of CKD

Approval was based on positive data from the phase 3 trial for chronic kidney disease


Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for the treatment of chronic kidney disease (CKD) in adults with and without type 2 diabetes.

Forxiga is the first ever approved medicine for the treatment of the disease in Japan.

The decision follows positive results from the DAPA-CKD phase 3 trial, which demonstrated that Forxiga reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39%.

Naoki Kashihara, the national coordinator of the trial in Japan and 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.”

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.”

Ono Pharmaceutical has distribution rights for Forxiga in Japan and will co-promote the drug for the treatment of CKD along with AstraZeneca.

Forxiga was approved as ‘Farxiga’ for the treatment of CKD in adults with and without type 2 diabetes in the US in April, after demonstrating results from a phase 3 study of the drug at the European Society of Cardiology (ESC) virtual congress in January. It was approved in the EU in August and according to AstraZeneca is currently under review in several other countries around the world.

Article by
Bryony Andrews

27th August 2021

From: Regulatory



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