Recently, Forxiga (Chinese trade name: Anda Tang, generic name: dapagliflozin) has been officially approved in China: for the treatment of heart failure with or without type 2 diabetes with reduced ejection fraction (HFrEF, NYHA II-IV) In adult patients, reduce the risk of cardiovascular (CV) death and hospitalization for heart failure (hHF).

　　Dapagliflozin is the first SGLT2 inhibitor officially approved for heart failure indications in China, which can significantly reduce the occurrence of cardiovascular death and heart failure worsening events. It is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor taken orally once a day.

　　At the beginning of May 2020, Farxiga (Dapagliflozin) received the world's first approval in the United States for the treatment of adult patients with HFrEF. So far, the drug has been approved for the treatment of adult patients with HFrEF in the United States, Europe, Japan and many countries and regions around the world.

　　Dapagliflozin (Forxiga) is the first SGLT2 inhibitor drug approved for the treatment of HFrEF and the first to be shown to significantly reduce cardiovascular (CV) death and cardiovascular (CV) deaths in patients with HFrEF (with or without type 2 diabetes) Drugs for the risk of hospitalization for heart failure. Previously, the drug has been approved for multiple types, which vary from country to country, including:

　　(1) Support diet and exercise to improve blood sugar control in patients with type 2 diabetes;

　　(2) It is used for type 2 diabetes patients with CV disease or multiple CV risk factors to reduce the risk of heart failure hospitalization. In the European Union and Japan, the drug is also approved for the treatment of type 1 diabetes, specifically: as an oral adjuvant therapy for insulin, used for insulin therapy but poor blood glucose level control and body mass index (BMI) ≥27kg/ m2 (overweight or obese) adult patients with type 1 diabetes (T1D), improve their blood sugar control.

　　The approval of dapagliflozin for heart failure indications in China is based on the positive results of the landmark DAPA-HF Phase III clinical trial published in the New England Journal of Medicine.

　　DAPA-HF Phase III clinical trials have shown that adding dapagliflozin to standard treatments (including ACEi or ARB), compared with placebo, can reduce cardiovascular death or heart failure worsening events (including heart failure hospitalization for hHF) The risk of a composite endpoint outcome is reduced by 26%, and the two components that make up the main composite endpoint contribute to overall efficacy. Dapagliflozin is the first SGLT2 inhibitor to achieve this effect. The safety of DAPA-HF Phase III clinical trials is consistent with the known safety of the drug. During the trial period, every 21 patients receiving treatment could avoid 1 cardiovascular death or heart failure hospitalization or 1 emergency medical visit related to heart failure.

　　In China, Forxiga (Chinese brand name: Anda Tang) was approved in March 2017 as a monotherapy for adults with type 2 diabetes to improve their blood sugar control.

　　But at the end of October 2020, the Forxiga (Chinese brand name: Andatang) label was updated to include data from the Milestone Cardiovascular Prognosis Study (CVOT) Phase III DECLARE-TIMI 58 study. This is the largest and most extensive CVOT study conducted for SGLT2 inhibitors so far. The results were published in the New England Journal of Medicine (NEJM) in January 2019. Data show that Forxiga reduces the combined risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in patients with type 2 diabetes (T2D).