New heart failure treatment approved in China

The National Medical Products Administration of China has granted marketing authorization for Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with preserved ejection fraction, Boehringer Ingelheim and Eli Lilly and Company have announced.

Following an adult type 2 diabetes mellitus and adult with heart failure with preserved ejection fraction, this is the third indication of Jardiance approved in China. Previously, empagliflozin has been approved in the United States and Europe for the treatment for all adults with symptomatic chronic heart failure, regardless of ejection fraction.

As a kind of rare, incurable, and life-threatening disease, heart failure is the indication of severity and final stage of various heart diseases, which mainly show symptoms like dyspnea, fatigue, and fluid retention.

There are over 60 million people worldwide are living with heart failure, and about 8.9 million heart failure patients in China, of which about half are diagnosed heart failure with preserved ejection fraction. More common in elderly women, the condition has been recognized as in need of remedy in the field of cardiovascular medicine due to its prevalence, poor outcomes and the absence of treatment options until now.

According to medical experts, In China, the prevalence of heart failure in people over 35 years old has reached 1.3 percent. While the existing treatment enhances the prognosis of the patients and improves the life quality of patients to a certain extent, it puts tremendous pressure on patients and their families and poses a great challenge to China's medical and health system.

This latest approval makes Jardiance the first and currently the only SGLT-2 inhibitor approved in China for the treatment of adult patients with symptomatic chronic heart failure, marking a significant scientific advance in the treatment of heart failure and bringing hope to patients with heart failure.

Julio Gay-Ger, president and general manager of Lilly China said: "the approval of the new indication marks another important milestone in the achievement of Jardiance, which has now covered the treatment of diabetes and heart failure and established an important treatment status. The vitality of sustainable development shown by the product drives us to carry on exploring multidisciplinary potential treatment options, providing more and better treatments for related diseases, and further improving the prognosis and quality of life of patients, which will extensively benefit Chinese patients and their families for a long time."

"Thanks to the reform of China's drug review, examination, and approval system, Jardiance was approved smoothly for a new indication in China in just a few months, which is a great affirmation of the innovative drug by the Chinese drug regulatory authorities," said Pavol Dobrocky, head of medicines for mankind business in Great China, Boehringer Ingelheim.