- A diabetes drug from Eli Lilly and Boehringer Ingelheim reduced the risk of heart-related death or hospitalization for heart failure in a large clinical trial of people with a difficult-to-treat form of the cardiovascular condition, the Indianapolis drugmaker said Tuesday.
- According to Lilly, the results are the first time a medicine has met its main goal in a late-stage study of adults who have heart failure with what's known as preserved ejection fraction, indicating the heart is still able to contract normally but doesn't fill with enough blood. The two companies did not disclose specific details.
- Another similarly structured study last year showed Lilly's drug, called Jardiance, worked in heart failure patients with reduced ejection fraction, the other major classification for the condition. Lilly has already filed for an expanded Food and Drug Administration approval in that heart failure type and expects a decision later this year. The company plans to apply for an OK in heart failure with preserved ejection fraction in 2021 as well.
Diabetes drugmakers have expended considerable resources proving their medicines can also reduce the risk of cardiovascular death. Lilly and Boehringer Ingelheim's testing of Jardiance in people with heart failure is an extension of those efforts and their success could greatly broaden use of their drug.
Tuesday's results are from the second of two large Phase 3 studies launched in March 2017. The first, which enrolled 3,730 adults, focused on heat failure with reduced ejection fraction, meaning the heart is too weak to pump out normal amounts of blood. Trial data showed treatment with Jardiance reduced the risk of cardiovascular death or hospitalization with heart failure by 25% compared to a placebo.
Lilly and Boehringer have now followed up that finding with another success. Jardiance "significantly" reduced risk versus placebo on the same measures in the second study of 5,988 heart failure patients with preserved ejection fraction, the two companies announced. No specific data were disclosed, but the companies said they plan to present results at the European Society of Cardiology's annual meeting in late August.
The presentation will likely be closely followed by doctors to determine the degree of benefit and whether certain subsets of trial participants responded more favorably to treatment. The trial goal is also a composite, measuring the time to first occurrence of either cardiovascular death or hospitalization for heart failure. Jardiance's effects may be more or less substantial on each of those measures when considered independently.
Still, the announcement from Lilly and Boehringer is a major finding. Sekar Kathiresan, a preventive cardiologist who now runs the gene editing startup Verve Therapeutics, predicted on Twitter that the results could eventually mean all patients with heart failure receive treatment with drugs that work like Jardiance.
Notably, Lilly and Boehringer's trials included people both with and without diabetes, potentially supporting use of the drug outside the disease for which it was originally developed.
Up until earlier this year, there were no therapies cleared for use in both the reduced and preserved forms of heart failure. In February, Novartis secured U.S. approval for its drug Entresto in people whose ejection fraction was below what's considered normal, a classification that included some patients with preserved ejection fraction.
But that expanded OK was based on results from a trial that did not meet its primary goal. A group of advisers to the FDA supported the clearance, however, based on the totality of data as well as evidence showing a benefit on the more narrow comparison of hospitalizations alone.
Lilly and Boehringer, should the detailed data back up their Tuesday announcement and support approval, could have a more convincing case to make.
Other companies hope to follow, though. AstraZeneca is testing its diabetes drug Farxiga, which works in the same way as Jardiance, in a trial of patients with preserved ejection fraction. The study, called DELIVER, is expected to wrap up in January 2022.