The FDA approval is supported by results from the Phase 3 EMPEROR-Preserved trial in which Jardiance showed a 21% reduction in relative risk
Empagliflozin, sold under the brand name Jardiance among others. (Credit: Anthony Morrow/Wikipedia)
Boehringer Ingelheim and Lilly have received the US Food and Drug Administration (FDA) approval for Jardiance (empagliflozin) 10mg to reduce the risk of cardiovascular death and hospitalisation in adults with heart failure.
In 2014, the drug was originally approved in the US, as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes.
It was also approved to reduce the risk of cardiovascular death in patients with type 2 diabetes and cardiovascular disease, and to reduce the risk of death and hospitalisation in patients with heart failure and low ejection fraction.
Jardiance is not advised for people with type 1 diabetes, as it is expected to increase the risk of diabetic ketoacidosis in this population.
The drug is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, due to reactions such as angioedema, and in patients on dialysis.
Jardiance is said to be the first and only heart failure therapy to significantly reduce the risk of cardiovascular death and hospitalisation for heart failure, regardless of ejection fraction.
Lilly product development vice president Jeff Emmick said: “This approval reinforces the potential of Jardiance as a crucial treatment option to help fill an urgent need for adults across the full spectrum of heart failure.
“Building on the indication for heart failure with reduced ejection fraction last year, this decision marks the third US FDA approval for Jardiance stemming from the EMPOWER program and adds to a growing legacy of leadership for the Boehringer Ingelheim and Lilly Alliance spanning cardiovascular disease and type 2 diabetes.”
The FDA approval is supported by results from the Phase 3 EMPEROR-Preserved trial in 5,988 adults with heart failure with more than 40% LVEF.
The Phase 3 study evaluated once-daily Jardiance 10mg compared to placebo once daily, both on top of standard of care therapy.
In the study, treatment using Jardiance showed a 21% reduction in relative risk for the composite primary endpoint of cardiovascular death or hospitalisation for heart failure.
In addition, Jardiance has reduced the 27% relative risk of first and recurrent hospitalisations for heart failure, in a key secondary endpoint analysis from the EMPEROR-Preserved trial.
Boehringer Ingelheim Pharmaceuticals cardio-metabolism and respiratory medicine clinical development and medical affairs vice president Mohamed Eid said: “The EMPEROR-Preserved trial demonstrated breakthrough benefits for a widely underserved group of people who have heart failure.
“With today’s news, Jardiance becomes the first and only heart failure treatment to show a statistically significant risk reduction in cardiovascular death and hospitalisation for heart failure in adults with heart failure, regardless of ejection fraction.
“This approval, with a decision for use in the EU by the European Commission, expected to follow, represents an important milestone in our efforts to redefine heart failure care and advance treatment options for people with a range of cardio-renal-metabolic conditions.”