Lilly, Boehringer's Jardiance hits main goal of heart failure study

Eli Lilly and Boehringer Ingelheim said Tuesday that a Phase III study of Jardiance (empagliflozin) in patients with chronic heart failure with preserved ejection fraction (HFpEF) met its primary endpoint. Top-line results from the EMPEROR-Preserved trial showed that the SGLT2 inhibitor significantly reduced risk for the composite of cardiovascular death or hospitalisation for heart failure compared to placebo.

Principal investigator Stefan Anker noted that HFpEF "has long been the most challenging form of heart failure to treat," but the EMPEROR-Preserved findings "should offer a significant breakthrough in cardiovascular medicine and a new hope for people with HFpEF."

Marketing filings to follow

The main goal of the trial, which evaluated Jardiance versus placebo in 5988 patients with HFpEF, was time to first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure. Full results are scheduled for presentation at the European Society of Cardiology (ESC) congress in August, while Eli Lilly and Boehringer Ingelheim said that regulatory submissions for Jardiance in this indication will be submitted this year.

The companies added that when taken together with data from the EMPEROR-Reduced trial, which evaluated Jardiance in chronic heart failure patients with reduced ejection fraction (HFrEF), the latest findings demonstrate the drug's efficacy "in all forms of heart failure regardless of ejection fraction." Results from the EMPEROR-Reduced study showed that Jardiance significantly lowered the combined relative risk of cardiovascular death or hospitalisation for heart failure by 25% compared to placebo.

Recent EU approval in HFrEF

Last month, the European Commission expanded approval of Jardiance to include adults with symptomatic chronic HFrEF, while an application is under review in the US with a decision expected later this year. The drug, which is also authorised to lower blood glucose in adults with type 2 diabetes, as well as to reduce cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease, generated sales of $312 million in the first quarter, up 17% year-on-year.

In February, Novartis obtained an expanded US label for Entresto (sacubitril/valsartan) to include reducing the risk of cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure. The decision made Entresto the first drug approved for use in both HFrEF and HFpEF. Meanwhile, AstraZeneca's Farxiga (dapagliflozin), which like Jardiance also inhibits SGLT2, saw its list of indications expanded by the FDA last year to include reducing the risk of cardiovascular death and hospitalisation for heart failure in adult HFrEF patients, regardless of diabetes status. Farxiga sales were up 54% in the first quarter at $625 million.

For related analysis, see ViewPoints: Latest win for Jardiance puts Eli Lilly in new showdown with AstraZeneca.

To read more Top Story articles, click here.