日本厚生劳动省3月24日批准阿斯利康公司Forxiga(达格列净，SGLT-2抑制剂)5，10mg片剂用于治疗2型糖尿病。Forxiga在2012年11月被EMA批准成为全球首个上市的SGLT-2抑制剂，也是FDA继强生Invokan(canagliflozin，2013/3/29)之后批准的第2个SGLT-2抑制剂。

AstraZeneca Snags Forxiga Approval in Japan

AstraZeneca announced that the Japanese Ministry of Health, Labor 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 Dec. 3 2013.

Fouzia Laghrissi-Thode, vice president, global product portfolio strategy for Cardiovascular and me-tabolism, 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 U.S. Food and Drug Administration (FDA) for the treatment of adults with type 2 diabetes on Jan. 8, supported by a robust clinical development program comprised of 24 clinical studies eva1uating 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 program also includes a cardiovascular outcomes trial which aims to enroll more than 17,000 patients.

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