Boehringer, Eli Lilly’s Jardiance Wins NMPA Approval for Heart Failure with Preserved Ejection Fraction

Boehringer Ingelheim and Eli Lilly (NYSE: LLY) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Jardiance (empagliflozin), an SGLT2 inhibitor, to treat heart failure in adult patients with preserved ejection fraction (HFpEF). Previously approved in China for type 2 diabetes and heart failure with reduced ejection fraction, Jardiance can now address a broader patient population.

Study Background
The approval is based on the global Phase III EMPEROR-Preserved study, which enrolled nearly 6,000 adult patients with HFpEF, with or without diabetes. Results showed Jardiance reduced the relative risk of cardiovascular death or heart failure hospitalization by 21%, meeting the primary endpoint. The drug also cut the risk of first and second hospitalizations by 27% and delayed kidney function decline.

Clinical Significance
The study’s findings highlight Jardiance’s efficacy in managing HFpEF, a condition with limited treatment options. The approval expands the drug’s use in China, aligning with global approvals for similar indications.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry