The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion on Jardiance® (empagliflozin) for treatment of symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced.
Empagliflozin was previously approved for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
If approved, the opinion would expand to be applicable for adults across the full spectrum of left ventricular ejection fraction (LVEF), including preserved ejection fraction (HFpEF).
Hope for heart failure patients
Professor Stefan Anker, Heart Failure Cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved Principal Investigator made the following remarks.
“For the very first time, we now have a treatment that will improve clinical results across the full spectrum of heart failure patients – regardless of ejection fraction.”
“Half of all heart failure patients are those with a preserved left ventricular ejection fraction.”
“They suffer symptomatically due to the absence of any approved beneficial therapies. Today’s positive opinion of EMA is a significant step forward in redefining clinical practice and will provide an additional lifeline to the millions of patients in Europe diagnosed with HFpEF.”
The positive opinion is based on results from the landmark EMPEROR-Preserved Phase III trial, which investigated the effect of empagliflozin 10 mg compared with placebo once-daily, both added to standard of care, in 5,988 adults with heart failure with LVEF over 40%.
Empagliflozin is a safe alternative
In the trial, empagliflozin demonstrated an impressive 21% relative risk reduction (3.3% absolute risk reduction, 0.79 HR, 0.69-0.90 95% CI) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure.
The benefit was regardless of ejection fraction or diabetes status.
Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim said, “We are delighted with the CHMP’s decision to recommend empagliflozin as a treatment for adults with chronic heart failure.”
“Understanding of the cardio, renal and metabolic systems enabled us to broaden from diabetes to heart failure, following the science to provide solutions to medicine’s greatest challenge.”
“We are proud to provide renewed hope to underserved patients, underscored by the unprecedented clinical benefit seen in the EMPEROR-Preserved clinical trial.”
“Today’s positive opinion addresses the single largest unmet need in cardiovascular medicine, confirming the potential of empagliflozin across the full spectrum of ejection fraction.”
Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly made these remarks.
“We are committed to ongoing research in these areas, and look forward to the results from the EMPA-KIDNEY trial, exploring the potential of empagliflozin in chronic kidney disease.”
The EMPEROR-Preserved trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.