The EC authorisation is based on the EMPEROR-Reduced trial, which showed a significant reduction in the combined relative risk
Boehringer Ingelheim and Lilly have secured the European Commission (EC) marketing authorisation for Jardiance (empagliflozin) to treat symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).
Jardiance is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to reduce cardiovascular death risk.
The drug was granted the US FDA Fast Track designation in September last year, and a positive recommendation by the EC’s Committee for Medicinal Products for Human Use (CHMP) last month.
Boehringer Ingelheim and Lilly initially joined forces in January 2011 to jointly develop compounds representing some of the largest diabetes treatment classes.
Boehringer Ingelheim corporate vice president and cardiometabolic medicine head Waheed Jamal said: “Jardiance was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes.
“We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status. We look forward to collaborating with regulators in Europe and beyond to ensure access to this trusted therapy.”
Lilly product development vice president Jeff Emmick said: “As we enter this new chapter of heart failure management, we can now look ahead to results from the EMPEROR-Preserved trial, expected this year.”
The EC authorisation is based on results from the EMPEROR-Reduced trial that evaluated the impact of Jardiance in reducing the risk of cardiovascular death or hospitalisation in adults with systolic heart failure.
EMPEROR-Reduced is a part of the EMPOWER clinical programme, alongside EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION trials.
In the trial, Jardiance demonstrated a significant (25%) reduction in the combined relative risk compared to placebo of cardiovascular death or hospitalisation due to heart failure.
According to key secondary endpoint analyses, Jardiance reduced 30% relative risk of first and recurrent hospitalisation for heart failure and slowed the decline in kidney function.
The results from the analysis were consistent in all subgroups of with or without chronic kidney disease patients, including those with severe renal impairment, Boehringer Ingelheim.
EMPEROR Programme clinical investigator Faiez Zannad said: “Today’s approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction.
“New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and more time with their families.”