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FDA grants enpagliflozin to treat ejection fraction as a breakthrough therapy for heart failure

 Last Update: 2021-09-20
 Source: Internet
 Author: User

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On September 9, Eli Lilly/Boehringer Ingelheim announced that the FDA has granted Jardiance (Engliflozin) the breakthrough therapy qualification for the treatment of adult heart failure (HFpEF) patients with preserved ejection fraction

The FDA's decision was mainly based on the results of a phase III trial code-named EMPEROR-Preserved

The results showed that, compared with placebo, empagliflozin reduced the relative risk of the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adult patients with HFpEF by 21%, and the benefit was not related to ejection fraction or diabetic status

The efficacy of empagliflozin in the EMPEROR-Preserved study is similar to the results of the EMPEROR-Reduced study in patients with chronic heart failure (HFrEF) with reduced ejection fraction.

Heart failure (HF) is a serious progressive disease that affects approximately 26 million people worldwide.

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