AstraZeneca Submits Dapagliflozin for Priority Review in China for Heart Failure Indication

Text | Baihuawen

On May 13, AstraZeneca’s application in China for a new indication of dapagliflozin was proposed for inclusion in the priority review program. This indication is for adult patients with heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and worsening heart failure, as well as to improve heart failure symptoms. The indication had just been approved by the U.S. Food and Drug Administration (FDA) on May 5.

Dapagliflozin is an SGLT2 inhibitor that received FDA approval on January 8, 2014. It is currently approved in the United States for three indications: 1) type 2 diabetes mellitus; 2) reducing the risk of hospitalization for heart failure in patients with type 2 diabetes or those at risk of cardiovascular death; and 3) reducing the risk of cardiovascular death or worsening heart failure in patients with heart failure with reduced ejection fraction (HFrEF).

On March 10, 2017, dapagliflozin was approved for marketing in China for the treatment of type 2 diabetes under the brand name Forxiga. In November 2019, dapagliflozin was included in the National Reimbursement Drug List (Class B) through national reimbursement negotiations, with prices set at RMB 2.56 per tablet (5 mg) and RMB 4.36 per tablet (10 mg).

Results from the Phase III DAPA-HF clinical trial involving 4,744 patients demonstrated that adding dapagliflozin to standard heart failure therapy reduced the relative risk of the primary composite endpoint by 26%. Specifically, the risk of cardiovascular death was significantly reduced by 18%, and the risk of worsening heart failure was significantly reduced by 30%.

Furthermore, the DAPA-HF trial demonstrated that dapagliflozin was equally effective in patients with and without type 2 diabetes, indicating that the reduction in heart failure hospitalization risk by SGLT2 inhibitors is independent of glycemic control.

The latest data from subgroup analyses also demonstrated that dapagliflozin reduced the incidence of the primary composite endpoint in patients with HFrEF receiving extensive pharmacological therapy, device-based therapy, and cardiac resynchronization therapy.

Heart Failure (HF) affects approximately 64 million people worldwide and is a leading cause of hospitalization among individuals aged 65 and older. It is estimated that half of patients with heart failure die within five years of diagnosis, a mortality rate comparable to that of the most common cancers in men (prostate and bladder cancer) and women (breast cancer).