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August 19, 2021

FDA grants approval to Boehringer-Lilly’s Jardiance to treat HFrEF

The approval is based on results from the global Phase III EMPEROR-Reduced trial in 3,730 HFrEF patients.

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) to lower the risk of cardiovascular death and hospitalisation in adults with heart failure with reduced ejection fraction (HFrEF).

HFrEF happens when the heart muscle does not contract efficiently, causing a reduced amount of blood to be pumped out to the body.

The FDA approval is based on data from the global, randomised, double-blind Phase III EMPEROR-Reduced clinical trial of 10mg Jardiance in 3,730 adult subjects with and without type 2 diabetes.

These patients had functional class II, III or IV heart failure for a minimum of three months and a left ventricular ejection fraction not exceeding 40%.

Data from the trial showed that Jardiance sustainably lowered the relative risk of time to cardiovascular death or hospitalisation for heart failure by 25% compared to placebo, meeting the primary composite goal.

The drug also significantly lowered the relative risk of first and recurrent hospitalisation for heart failure by 30%, a main secondary goal.

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Jardiance’s safety in the trial was in line with its already established profile.

Boehringer Ingelheim Pharmaceuticals Cardio-Metabolism and Respiratory Medicine Clinical Development and Medical Affairs vice-president Mohamed Eid said: “In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing the risk of cardiovascular death and hospitalisation for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care.

“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.”

Jardiance can be used in HFrEF patients who have an estimated glomerular filtration rate (eGFR) as low as 20mL/min/1.73 m2.

The drug is not intended for individuals with type 1 diabetes as it could cause a diabetic ketoacidosis risk, Lilly added.

In March last year, the FDA granted fast track designation for the evaluation of empagliflozin to treat chronic kidney disease in adults.

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