Jardiance now approved by PMDA in Japan for use in patients with chronic heart failure with preserved ejection fraction (HFpEF)- Nippon Boehringer + Eli Lilly.
Nippon Boehringer Ingelheim’s SGLT2 inhibitor Jardiance (empagliflozin) has obtained a label update from PMDA in Japan allowing its use in patients with chronic heart failure with preserved ejection fraction (HFpEF) in addition to those with heart failure with reduced ejection fraction (HFrEF).
The drug was approved in November 2021 for patients with chronic heart failure receiving standard therapy. However, its label previously restricted its use to HFrEF, noting that its efficacy and safety for HFpEF have not been established.
This statement on the lack of evidence for HFpEF has been deleted in the latest update after a global PIII trial confirmed the drug’s efficacy in this patient population. In the new label, the company added the results of the PIII study (EMPEROR-Preserved/1245.110) conducted in HFpEF patients.The label update was announced on April 6 by the company and its partner Eli Lilly Japan as well as the Pharmaceuticals and Medical Devices Agency (PMDA).
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