Boehringer & Eli Lilly’s Jardiance obtains EU nod to cure heart failure

Pharmaceutical giants C.H. Boehringer Sohn AG & Ko. KG and Eli Lilly & Company have announced to have received marketing authorization from the European Commission, for their chronic heart failure treatment drug, Jardiance® (Empagliflozin).

The recent development is an extension of a positive recommendation received from the Committee for Medicinal Products for Human Use (CHMP). The recently approved Jardiance will now be used by adults suffering from chronic heart failure and reduced ejection fraction (systolic heart failure).

Notably, the marketing authorization has been given based on the EMPEROR-Reduced clinical trial in which the use of empagliflozin displayed a whopping 25% reduction in the combined relative risk, as compared to placebo of cardiovascular hospitalization or death due to heart failure.

The outcomes from the clinical endpoints were similar in subgroups with or without type 2 diabetes. Moreover, secondary endpoint analysis demonstrated that the drug delayed the decline in kidney function while also reducing the relative risk of first and recurrent hospital admissions for heart failure by 30%.

EMPEROR Program clinical investigator, Dr. Faiez Zannad, was quoted saying that the approval brings in an important new treatment that will help millions of Europeans suffering from symptomatic chronic heart failure with reduced ejection fraction.

He further added that new treatment options such as Jardiance will prove to be lifesavers, and will reduce the hospitalization rate, allowing patients to have more quality time with their loved ones.

Meanwhile, some experts have claimed that heart failure is often associated with other afflictions of cardio-renal-metabolic systems such as kidney disease and type 2 diabetes. Owing to the intertwined nature of these systems, recovery in one system can effectuate positive outcomes throughout the others.

The EMPEROR-Reduced trial forms part of the EMPOWER clinical program, which is the broadest of any SGLT2 inhibitor studying the effect of empagliflozin on patients across the ambit of cardio-renal-metabolic ailments.

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