The US FDA approved Jardiance based on results from the Phase 3 EMPEROR-Reduced trial, in which the drug reduced the risk of cardiovascular death or hospitalisation
Eli Lilly and Company's Corporate Center in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia.)
Boehringer Ingelheim and Lilly have received the US Food and Drug Administration (FDA) approval for their Jardiance (empagliflozin) 10mg to treat heart failure with reduced ejection fraction (HFrEF).
Jardiance was indicated to reduce the risk of cardiovascular death plus hospitalisation due to heart failure, in adults with HFrEF.
In June this year, the European Commission (EC) has granted marketing authorisation for the drug to treat symptomatic chronic heart failure with reduced ejection fraction.
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.
It can be used in adults with HFrEF with an eGFR lower than 20 mL/min/1.73 m2.
Lilly product development vice president Jeff Emmick said: “Today’s approval is significant for the millions of people diagnosed with this form of heart failure, offering additional hope for those who have seen limited new treatment options over the last decade.
“Following EMPA-REG OUTCOME, this is the second US regulatory decision stemming from the EMPOWER clinical trial program, which is exploring the impact of Jardiance on major clinical cardiovascular outcomes.
“Jardiance is already a recognized leader for adults with type 2 diabetes, including those who also have established cardiovascular disease.
“We’re excited to build on that legacy with this new indication that establishes Jardiance as an effective treatment for adults with heart failure with reduced ejection fraction – regardless of whether they have type 2 diabetes.”
HFrEF occurs when the heart muscle fails to contract effectively, resulting in reduced volume of blood being pumped to the body, compared to a normal functioning heart.
The FDA approval is based on results from the Phase 3 EMPEROR-Reduced trial, which evaluated the effect of Jardiance 10mg plus standard of care compared to placebo.
The Phase 3 trial enrolled 3,730 adults with and without type 2 diabetes who had heart failure of functional class II, III or IV, and a left ventricular ejection fraction of 40% or less.
In the study, Jardiance reduced the relative risk of cardiovascular death or hospitalisation for heart failure by 25% versus placebo, the primary composite endpoint.
Also, the drug reduced the relative risk of first and recurrent hospitalisation for heart failure by 30%, according to a key secondary endpoint analysis.
The Phase 3 trial demonstrated that the safety profile of the drug was consistent with the well-established safety profile of Jardiance.
Boehringer Ingelheim Pharmaceuticals clinical development and medical affairs, cardio-metabolism and respiratory medicine vice president Mohamed Eid said: “Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalization for heart failure.
“In the EMPEROR-Reduced trial, Jardiance protected a broad range of adults with heart failure with reduced ejection fraction by reducing risk of cardiovascular death and hospitalization for heart failure, regardless of their baseline heart failure medications or type 2 diabetes status, when added to standard of care.
“Today’s FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorisation for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure.”