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New data show efficacy in all forms of heart failure regardless of ejection fraction.
Results from a major phase 3 trial show that the blockbuster heart medication Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly & Co. is the first therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF).
The new results from the EMPEROR-Preserved trial, when added to the EMPEROR-Reduced trial results, demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction, Boehringer Ingelheim and Lilly said in a press release.
“No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” Mohamed Eid, M.D., vice president, clinical development and medical affairs, cardio-metabolism and respiratory medicine at Boehringer Ingelheim Pharmaceuticals, said in a statement.
Lilly reported that its global revenue for Jardiance for the first quarter of 2021 was $312 million, up 17% from the same quarter last year. U.S. revenue for Jardiance increased 5%, to $151.2 million, driven by increased demand, Lilly said.
One of Jardiance’s primary competitors, Farxiga (dapagliflozin) from AstraZeneca and Bristol Myers Squibb, is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction, but is not recommended for patients with type 1 diabetes, according to the prescribing information. However, AstraZeneca and BMS are conducting a phase 3 for Farxiga’s use in treating HFpEF.
Another major competing product is Entresto (sacubitril/valsartan)from Novartis, which garnered FDA approval to treat chronic heart failure — including most patients with reduced and preserved ejection fractions — earlier this year.
Meanwhile, the EMPEROR-Preserved results should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF, which is an increasingly prevalent public health issue, said Professor Stefan Anker, heart failure cardiologist at Charité Berlin, Germany, and EMPEROR-Preserved principal investigator. “HFpEF has long been the most challenging form of heart failure to treat,”
The totality of the data from the EMPEROR-Preserved trial marks a “possible new chapter in heart failure, supporting the potential of Jardiance to become the first SGLT2 inhibitor to treat a defined population of adults with heart failure with either preserved or reduced ejection fraction,” Eid added.
The EMPEROR-Preserved trial investigated Jardiance 10 mg compared with placebo. Full results from the EMPEROR-Preserved trial are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 27.
Jardiance is not approved to treat heart failure in the United States. A supplemental New Drug Application (sNDA) for Jardiance to reduce the risk of cardiovascular death or hospitalization for heart failure in adults with HFrEF has been submitted to the FDA, with a decision expected later this year, Boehringer Ingelheim and Lilly said.
Research is ongoing regarding Jardiance’s effects on hospitalization for heart failure and mortality in post-myocardial infarction (heart attack) patients with high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease.