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.
“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,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
The DAPA-CKD trial
The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of standard-of-care (SoC) treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, 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%, the primary composite endpoint, compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. Forxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo.8 The safety and tolerability of Forxigawere consistent with the well-established safety profile of the medicine.
Forxiga (known as Farxiga in the US) was recently 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 several other countries around the world. Forxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). It is also approved for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D.
In 2013, AstraZeneca K.K. (AZKK), a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical Co., Ltd. (Ono) for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga in Japan and has been co-promoting it with AZKK for the treatment of T2D, T1D and chronic HF. Both Companies will co-promote for the treatment of CKD.
Photo of Mene Pangalos: AstraZeneca