AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FORXIGA® (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a once-daily oral treatment for type 2 diabetes. The FORXIGA application was submitted to the MHLW by Bristol-Myers Squibb K.K.. AstraZeneca and Ono Pharmaceutical entered into an agreement to co-promote FORXIGA on 3 December 2013.
Fouzia Laghrissi-Thode, Vice President, Global Product Portfolio Strategy for Cardiovascular and Metabolism, said: “In collaboration with our partner Ono, we are pleased to provide FORXIGA as a new treatment option for patients in Japan, where there are an estimated 9.5 million people living with type 2 diabetes. The approval of FORXIGA reinforces AstraZeneca’s focus on both diabetes and Japan as two of our key growth drivers.”
FORXIGA is a highly selective and reversible inhibitor of sodium-glucose cotransporter 2 that works independently of insulin to help remove excess glucose from the body. Currently approved in more than 40 countries globally, FORXIGA was the first SGLT2 inhibitor in the world to gain regulatory approval to treat type 2 diabetes in Europe in November 2012. It was approved by the US Food and Drug Administration for the treatment of adults with type 2 diabetes on 8 January 2014, supported by a robust clinical development programme comprised of 24 clinical studies evaluating safety and efficacy of FORXIGA. The studies included more than 11,000 adults with type 2 diabetes, with more than 6,000 patients treated with dapagliflozin. The on-going global clinical development programme also includes a cardiovascular outcomes trial which aims to enroll more than 17,000 patients.