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US approval for Boehringer Ingelheim, Lilly's heart failure drug Jardiance

Jardiance (empagliflozin) has been approved by the US Food and Drug Administration (FDA) to reduce the risk of cardiovascular death plus hospitalisation for adults with heart failure with reduced ejection fraction (HFrEF).

Approval for the Boehringer Ingelheim and Eli Lilly drug is based on results from its phase III trial, which investigated the effect of Jardiance on adults with and without type 2 diabetes who had heart failure and a left ventricular ejection fraction of 40% or less. Jardiance was found to reduce the risk of death or hospitalisation for heart failure by 25%.

"Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalisation for heart failure," said Mohamed Eid, VP clinical development and medical affairs, cardio-metabolism and respiratory medicine, Boehringer Ingelheim.

"Today's FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorisation for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure. We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions," he added.

19th August 2021

http://www.pharmatimes.com/

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