Jardiance® (Empagliflozin) Approved in China for the Treatment of Adults with Heart Failure with Reduced Ejection Fraction

ShanghaiJune 10, 2022/PR Newswire/ --Boehringer Ingelheim and Eli Lilly jointly announced that the SGLT2 inhibitor Jardiance from their diabetes alliance^®(General name: Empagliflozin Tablets) has been approved by the China National Medical Products Administration for a new indication, used to treat adult patients with heart failure with reduced ejection fraction, with or without diabetes.Jardiance^®It was first approved for marketing in China in 2017, for the treatment of adult patients with type 2 diabetes.

Heart failure is the severe manifestation and end-stage of various heart diseases, mainly characterized by dyspnea, fatigue, and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema), among others.^[4]According to the "2022 AHA/ACC/HFSA Guidelines for Heart Failure Management," heart failure can be divided into four types based on the left ventricular ejection fraction (LVEF), which is the percentage of blood pumped out with each heartbeat. These include heart failure with reduced ejection fraction (HFrEF, LVEF ≤40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF between 41% and 49%), heart failure with preserved ejection fraction (HFpEF, LVEF ≥50%), and heart failure with improved ejection fraction (HFimpEF, previously LVEF ≤40%, later increased to >40%).^[5]According to statistics, there are approximately 8.9 million heart failure patients in China.^[2]，[3]In China, the large number of patients with hypertension, coronary heart disease, and diabetes, coupled with the increasingly serious aging population, has led to a vast "reserve army" of heart failure.^[6]。

Jardiance^®The approval of the new indication is based on the EMPEROR-Reduced clinical trial within the EMPOWER Heart Failure study. This trial targeted adult heart failure patients with reduced ejection fraction, with or without diabetes. The trial results demonstrated,Empagliflozin treatment significantly reduces the risk of the composite endpoint of cardiovascular death and hospitalization for heart failure.25%，The primary endpoint predefined in the trial was reached. Meanwhile, the analysis of key secondary endpoints in the trial indicated that,Empagliflozin significantly reduces the risk of first and subsequent hospitalizations for heart failure.30%, and significantly delay the decline of renal function^[7]The trial covered nearly 4,000 people, and the full results of the clinical trial were published in 2020 in The New England Journal of Medicine.

Professor Zhang Jian, the principal investigator in China for the EMPEROR-Reduced study and a professor at Fuwai Hospital, Chinese Academy of Medical Sciences, stated: "Over the past 30 years, although significant progress has been made in understanding the mechanisms, pathophysiology, prevention, and treatment of heart failure, the overall prognosis remains poor, with high mortality and rehospitalization rates. Under current combination drug therapies, the 5-year mortality rate for heart failure patients still exceeds 50%, which not only imposes dual physical and psychological pressures on patients but also poses a challenge to China’s healthcare system." Jardiance^®The approval of this new indication in China brings a completely new treatment option for patients with heart failure with reduced ejection fraction, and is expected to become the new standard for heart failure treatment.

Eli Lilly China President and General Manager Jeroen van de Walle said, "We are very pleased to see Jardiance^®Expanding its indications further in China, it has brought new treatment options for heart failure patients, which also lays the foundation for Jardiance.^®In the two treatment areas of diabetes and heart failure, we hold an important position. As the landscape of heart failure treatment expands, we will continue to work on improving drug accessibility, providing more Chinese patients with better medication options, and expanding comprehensive clinical benefits.

Dr. Dong Bowen, Head of Human Pharma Business at Boehringer Ingelheim Greater China, said: "Jardiance^®"It is the first SGLT2 inhibitor proven to have cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes. The approval of its new indication marks another significant milestone for this drug. Moving forward, we will continue to focus on patient needs, advance new drug development, and seek more life-changing treatments for patients with heart failure and major metabolic diseases."

Following the EMPEROR-Reduced trial, empagliflozin also achieved positive results in the EMPEROR-Preserved Phase III clinical trial, becoming the first successful clinical trial for heart failure with preserved ejection fraction. Currently, empagliflozin has been approved in the United States and Europe for the treatment of all symptomatic adult heart failure, regardless of reduced or preserved ejection fraction.