British drug major AstraZeneca (AZN.L,AZN) announced Thursday that its Japan’s Ministry of Health, Labour and Welfare has approved Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 or SGLT2 inhibitor, to treat chronic kidney disease or CKD in adults with and without type-2 diabetes.
The approval 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. Its diagnosis rates remain low and up to 90% of patients are unaware they have the disease.
The company noted that Forxiga is the first ever approved medicine for the treatment of the 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.”
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 type-2 diabetes or T2D. It is currently under review in several other countries around the world.
In 2013, AstraZeneca K.K., a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical Co., Ltd. for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga in Japan.
Source: Read Full Article