The National Institute for Health and Care Excellence (NICE) announced Thursday that empagliflozin, (Jardiance, marketed by Boehringer Ingelheim and Eli Lilly) is recommended for use as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults.
Empagliflozin is licensed for use in the treatment of adults with symptomatic chronic heart failure regardless of ejection fraction, alongside existing indications in chronic kidney disease and type 2 diabetes.
The U.S. Food and Drug Administration (FDA) has recently approved Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.
This recommendation will expand the use of empagliflozin, which was previously recommended by NICE in March 2022 for treating symptomatic chronic heart failure in adults with reduced ejection fraction, as part of optimised standard of care.
The positive Final Draft Guidance (FDG) from NICE means that empagliflozin will be accessible through the NHS to all eligible adult patients with symptomatic chronic heart failure in England and Wales, regardless of ejection fraction.
Professor Ahmet Fuat, Education and Research Lead at the Primary Care Cardiovascular Society said that the Primary Care Cardiovascular Society are delighted that NICE has now provided a draft recommendation for empagliflozin as another option for treating symptomatic chronic heart failure with preserved and mildly reduced ejection fraction in adults. He said that, until recently, unlike heart failure with reduced ejection fraction, there have been limited treatment options for this group of patients, despite the trend of increasing prevalence of symptomatic chronic heart failure with preserved and mildly reduced ejection fraction.
Nick Hartshorne-Evans, Chief Executive and Founder of the Pumping Marvellous Foundation, the leading patient organisation for people living with heart failure, said that the approval of empagliflozin represents a positive step for people living with heart failure in England and Wales, approximately half of whom have heart failure with preserved or mildly reduced ejection fraction. “We are delighted that this decision brings another treatment option to people living with this severe long-term condition that significantly impacts their day-to-day activities,” he said.
What does Boehringer Ingelheim say about the announcement?
Dr Christoph Zehendner, Medical Director, Boehringer Ingelheim UK and Ireland, said: “In line with the UK Government’s Life Sciences Vision, NHS Long Term Plan and Major Conditions Strategy, we are committed to improving patient outcomes for the large population of people living with the interconnected cardio-renal-metabolic conditions by providing effective treatment options.”
He said that this positive NICE recommendation marks another important milestone for empagliflozin and follows the recent MHRA approval in chronic kidney disease in September 2023.
This NICE recommendation was based on results from the EMPEROR-Preserved Phase III clinical trial, which demonstrated that empagliflozin achieved its primary composite endpoint (cardiovascular death or hospitalisation for heart failure) in adults with an ejection fraction of more than 40%, compared to placebo, both added to background therapy.
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