Forxiga label update from MHLW (Japan) to allow use for chronic heart failure, irrespective of left ventricular ejection fraction
AstraZeneca and Ono Pharmaceutical have secured a label update from Japanese regulators for their SGLT2 inhibitor Forxiga (dapagliflozin), which allows the drug’s use for chronic heart failure, irrespective of left ventricular ejection fraction (LVEF)
The update means that Forxiga can now be used to treat patients with chronic heart failure with preserved ejection fraction (HFpEF) in addition to those with heart failure with reduced ejection fraction (HFrEF).
In Japan, Forxiga was approved in November 2022 for the indication of chronic heart failure in patients who receive the standard of care. The original label stated that the safety and efficacy of Forxiga have not been established for HFpEF, and therefore, it should be administered to patients with HFrEF. This description was deleted in the latest update.The change is based on the results of a global PIII study,titled DELIVER, conducted in HFpEF patients.
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