Boehringer Ingelheim and Eli Lilly Submit New Drug Application in China for Jardiance® (empagliflozin) to Treat Adults with Heart Failure with Preserved Ejection Fraction

SHANGHAI, Oct. 11, 2021 /PRNewswire/ -- On Sept. 30, 2021, Boehringer Ingelheim and Eli Lilly jointly announced,has formally submitted to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) under its diabetes allianceSGLT2 Inhibitor Jardiance^®(Generic Name: Empagliflozin Tablets) Registration Application for a New Indication in Adult Patients with Heart Failure with Preserved Ejection FractionPreviously, empagliflozin was approved in China for the treatment of type 2 diabetes.

Heart failure is a complex clinical syndrome caused by structural and/or functional abnormalities of the heart due to various etiologies, leading to impaired ventricular systolic and/or diastolic function. It is a common, severe, and incurable chronic disease. According to statistics, heart failure affects over 60 million people worldwide.^[i], patients with heart failure with preserved ejection fraction (HFpEF) account for approximately half of them^{[ii][iii][iv]}. HFpEF is more commonly observed in elderly women, and the majority of patients present with comorbidities.^[v]Due to its high prevalence, poor prognosis, and the lack of clinically approved therapies to date, HFpEF is recognized as a major unmet need in cardiovascular medicine.^[vi]。

`Jardiance`^®The regulatory application for the indication in adult patients with heart failure with preserved ejection fraction is based on the EMPEROR-Preserved Phase III clinical trial, the results of which showed that:Empagliflozin inshowed a 21% relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adult patients with HFpEF,This result is remarkable.。Additionally, analysis of the key secondary endpoints in the trial demonstrated that,Empagliflozin can also reduce the relative risk of first and recurrent hospitalizations for heart failure by27%, and significantly slowed the decline in renal function.The complete results of this clinical trial were presented in August this year at the European Society of Cardiology (ESC) Congress and simultaneously published in *The New England Journal of Medicine*.

Dr. Wang Li, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated: "Heart failure is a severe manifestation and terminal stage of various heart diseases, with a resulting rehospitalization rate as high as 24.5% and a post-diagnosis mortality rate nearly comparable to that of common malignant tumors."^[vii], is one of the most dangerous cardiovascular diseases. To date, heart failure with preserved ejection fraction has been difficult to treat effectively with conventional therapies. Jardiance^®"The clinical trial results for this indication have brought great hope to patients with this type of heart failure and are poised to break the therapeutic impasse in China, where no approved therapies currently exist for this disease area!"

Dr. Zhang Wei, Global Vice President and Head of Medical and Clinical R&D for Greater China at Boehringer Ingelheim, stated: “Delivering innovative, effective, and safe treatment options to Chinese patients at the earliest opportunity has always been our commitment. We are pleased to submit the registration application for empagliflozin for the indication of adult patients with heart failure with preserved ejection fraction (HFpEF) in parallel with our global submission, which means that a vast number of Chinese heart failure patients will have the opportunity to benefit from this breakthrough innovative drug concurrently with patients worldwide. We look forward to working closely with the relevant authorities to advance the approval of this indication, providing physicians and patients with a novel treatment option, addressing a significant unmet clinical need, and alleviating the disease burden for millions of Chinese patients with heart failure with preserved ejection fraction and their families.”

[i] GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2017;390:1211; 2.;

[ii] Gurwitz JH, Magid DJ, Smith DH, Goldberg RJ, McManus DD, Allen LA, Saczynski JS, Thorp ML, Hsu G, Sung SH, Go AS. Contemporary prevalence and correlates of incident heart failure with preserved ejection fraction. Am J Med. 2013 May;126(5):393-400.

[iii] China-HF

[iv] Shiba N, Nochioka K, Miura M, Kohno H, Shimokawa H; CHART-2 Investigators. Trend of westernization of etiology and clinical characteristics of heart failure patients in Japan--first report from the CHART-2 study. Circ J. 2011;75(4):823-33.

[v] REPRESENT-HF study. Data on file.

[vi] Shah SJ, Borlaug B, Kitzman D, et al. Research priorities for heart failure with preserved ejection fraction. Circulation. 2020;141:1001–26.

[vii] Ponikowski P, Anker S D, AlHabib K F, et al. Heart failure: preventing disease and death worldwide[J]. ESC Heart Failure, 2014, 1(1): 4-25.