Dapagliflozin
China [CN] dapagliflozin (ForxigaTM), a novel anti-diabetic drug jointly developed by Bristol-Myers Squibb and Astrazeneca, was approved for marketing by the European Medicines Agency (EMA) on November 12, 2012. It is the first SGLT2 inhibitor approved for marketing in the treatment of type 2 diabetes. It can be an important option in the drug treatment of diabetes and is suitable for adults with type 2 diabetes as an auxiliary diet and exercise to improve blood sugar control. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor. On January 8, 2014, the U.S. Food and Drug Administration (FDA) announced the approval of dapagliflozin for the treatment of type 2 diabetes. Meanwhile, Chemicalbook requires manufacturers to conduct post-marketing studies on the drug-related risks. The post-marketing trials required by the FDA include a cardiovascular outcome trial evaluating the cardiovascular risk of patients at high risk of cardiovascular disease at baseline after treatment with dapagliflozin and a study evaluating the risk of bladder cancer in recruited patients. Another study will evaluate the promoting effect of the drug on bladder tumors in rodents. Two studies will evaluate the pharmacokinetics, efficacy and safety of dapagliflozin in pediatric patients; An enhanced pharmacovigilance program will monitor liver abnormalities and pregnancy outcome reports in patients treated with dapagliflozin. Dapagliflozin will be sold by HaoeyouPharmacy under the brand name Farxiga.
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