Boehringer Ingelheim and Eli Lilly’s Empagliflozin Gains New NMPA Approval for Heart Failure with Reduced Ejection Fraction

Today (June 10), the official website of the China National Medical Products Administration (NMPA) announced that empagliflozin tablets (Jardiance) have been approved for a new indication in China. Empagliflozin is an SGLT2 inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly and Company. It won the "International Prix Galien" Best Pharmaceutical Agent of the Year award, known as the "Nobel Prize of the pharmaceutical industry," in 2018. Previously, the drug had been approved in China for patients with type 2 diabetes. According to publicly available information, this approval is for the treatment of adult patients with heart failure with reduced ejection fraction.

Screenshot source: NMPA official website

Empagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor taken orally once daily. In patients with type 2 diabetes with higher blood glucose levels, empagliflozin prevents the kidneys from reabsorbing sugar by inhibiting SGLT2, allowing more sugar to be excreted through urine. Additionally, empagliflozin reduces salt reabsorption, increasing salt excretion and lowering fluid load in the vascular system. The changes in sugar, salt, and water metabolism induced by empagliflozin may contribute to reducing cardiovascular death in affected patients.

In the United States, empagliflozin has been approved by the FDA for the treatment of multiple indications, including type 2 diabetes, to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease, as well as to reduce the risk of cardiovascular death and hospitalization in adult patients with heart failure with reduced ejection fraction. In November 2021, the FDA also granted priority review status to the supplemental New Drug Application (sNDA) for empagliflozin for reducing the risk of cardiovascular death and hospitalization in heart failure patients, regardless of the patient’s left ventricular ejection fraction.

In China, empagliflozin was first approved in September 2017 for improving glycemic control in patients with type 2 diabetes. According to a press release previously issued by Eli Lilly and Company, this approval is for the treatment of adult patients with heart failure with reduced ejection fraction, with or without diabetes.