AstraZeneca's Dapagliflozin Label Update Approved by China's NMPA Incorporating DECLARE-TIMI 58 Cardiovascular Outcomes Data

On October 28, AstraZeneca announced that the National Medical Products Administration (NMPA) of China had approved an update to the Chinese prescribing information for Forxiga® (generic name: dapagliflozin), incorporating relevant data from the Phase 3 DECLARE-TIMI 58 clinical study.

The DECLARE-TIMI 58 study demonstrated that, compared with placebo, dapagliflozin significantly reduced the risk of hospitalization for heart failure (hHF) or cardiovascular death in adult patients with type 2 diabetes who had established cardiovascular disease or multiple cardiovascular risk factors. The safety profile observed in the study was consistent with the known safety profile of dapagliflozin. The DECLARE-TIMI 58 study is one of the largest cardiovascular outcomes trials of SGLT2 inhibitors conducted to date.

Mr. Ruud Dobber, Executive Vice President of AstraZeneca and Head of the Biopharmaceuticals Business Unit, stated, “Heart failure is one of the most common early cardiovascular complications in patients with type 2 diabetes. Data from the DECLARE-TIMI 58 study demonstrate that dapagliflozin can reduce the risk of hospitalization for heart failure in these patients. We hope that the successful update of the product labeling in China will enable more Chinese patients to benefit from this advantage.”

Currently, there are an estimated 463 million people with diabetes worldwide, including approximately 120 million in China. Patients with type 2 diabetes are 2 to 5 times more likely to develop chronic heart failure (HF) than those without type 2 diabetes. The global number of people with diabetes is projected to reach 578 million by 2030 and 700 million by 2045. Heart failure is a serious, life-threatening condition caused by the heart's inability to pump sufficient blood to the rest of the body. There are approximately 64 million patients with heart failure worldwide (half of whom have heart failure with reduced ejection fraction), and nearly half of these patients die within five years of diagnosis.

Dapagliflozin is indicated as monotherapy and in combination therapy to improve glycemic control in adult patients with type 2 diabetes. The recent approval by China’s National Medical Products Administration (NMPA) to update the Chinese labeling for dapagliflozin represents another recognition of the DECLARE-TIMI 58 study, following its market authorization in the European Union in August 2019 and the U.S. FDA indication approval in October 2019. Previously, the U.S. FDA approved dapagliflozin to reduce the risk of hospitalization for heart failure in adult patients with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.

On the DECLARE-TIMI 58 Study

The DECLARE-TIMI 58 study was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial sponsored by AstraZeneca. It aimed to evaluate the cardiovascular outcomes of dapagliflozin versus placebo in adult patients with type 2 diabetes (T2D) at risk for cardiovascular events (including multiple cardiovascular risk factors or established cardiovascular disease), while also assessing key secondary renal endpoints. The DECLARE-TIMI 58 study enrolled more than 17,000 patients from 882 centers across 33 countries. It was independently conducted by the TIMI Study Group (Boston, Massachusetts) in collaboration with the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

About Dapagliflozin

Dapagliflozin is the first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor for the treatment of adults with type 2 diabetes mellitus. Administered orally once daily, it can be used as monotherapy or in combination with diet and exercise in patients with inadequate glycemic control, offering additional benefits of weight reduction and blood pressure lowering.

In May 2020, dapagliflozin was approved in the United States for the treatment of adult patients with heart failure with reduced ejection fraction (HFrEF) (NYHA class II-IV), with or without type 2 diabetes mellitus, to reduce the risk of cardiovascular death and hospitalization for heart failure. The significant efficacy of dapagliflozin in chronic kidney disease (CKD) has also been demonstrated. In August of the same year, the complete results of the Phase 3 DAPA-CKD clinical trial were published, showing that dapagliflozin met all primary and secondary endpoints. Furthermore, in October this year, the U.S. FDA granted dapagliflozin Breakthrough Therapy Designation to accelerate the review and approval process for its use in patients with chronic kidney disease, with or without type 2 diabetes mellitus.

References:

[1] Major Update | Cardiovascular Outcome Benefits of Dapagliflozin Approved for Inclusion in the Product Labeling in China. Retrieved 2020-10-28, from https://mp.weixin.qq.com/s/Ow-5y5tVoBpVpgG8V2qd8Q

Source: Jike Pharmaceutical News

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