Lilly, Boehringer say diabetes drug first to achieve hard-to-treat coronary heart failure


Diving letter:

  • 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 cardiovascular disease, the Indianapolis-based drug maker said Tuesday.
  • According to Lilly, the results are the first time a drug has met its primary target in a late-stage study in adults with heart failure with what is known as a preserved ejection fraction, which suggests that the heart can still contract normally but not fill with enough blood. The two companies did not provide precise details.
  • Another similarly structured study last year showed that Lilly’s drug called Jardiance worked in heart failure patients with reduced ejection fraction, the other major classification for the disease. Lilly has already applied for expanded Food and Drug Administration approval for this type of heart failure and is expecting a decision later this year. The company plans to apply for an OK in heart failure with preserved ejection fraction in 2021 as well.

Dive Insight:

Diabetes drug makers have invested significant resources in proving that their drugs can also lower the risk of cardiovascular death. Lilly and Boehringer Ingelheim’s testing of Jardiance in people with heart failure is an extension of that effort, and its success could expand the use of their drug significantly.

Tuesday’s results come from the second of two large phase 3 studies that started in March 2017. The first, which involved 3,730 adults, focused on heat failure with reduced ejection fraction, meaning the heart is too weak to pump out normal amounts of blood. Study data showed that treatment with Jardiance reduced the risk of cardiovascular death or hospitalization with heart failure by 25% compared to placebo.

Lilly and Boehringer have now followed this finding with another success. In the second study with 5,988 heart failure patients with preserved ejection fraction, Jardiance “significantly” reduced the risk compared to placebo with the same measures, announced the two companies. No specific data was disclosed, but the companies said they plan to present the results at the European Society of Cardiology’s annual meeting in late August.

The presentation will likely be followed closely by clinicians to determine the level of benefit and whether certain subsets of study participants responded better to treatment. The study objective is also a composite objective that measures the time to first onset of cardiovascular death or hospitalization for heart failure. The impact of Jardiance on each of these actions, when viewed independently, can be more or less significant.

Still, the announcement by Lilly and Boehringer is an important insight. Sekar Kathiresan, a preventive cardiologist who now runs gene editing startup Verve Therapeutics, predicted on Twitter that the results could eventually mean that all heart failure patients will be treated with drugs that work like Jardiance.

In particular, Lilly and Boehringer’s studies included people with and without diabetes, which may aid the drug’s use outside of the disease for which it was originally designed.

Until the beginning of this year, there were no approved therapies for either the reduced or preserved forms of heart failure. In February, Novartis received US approval for its drug Entresto in patients whose ejection fraction was lower than normal, a classification that included some patients who received ejection fraction.

But this extended OK was based on the results of a study that failed to achieve its primary goal. However, a group of FDA advisors advocated the clearance based on the entirety of the data and the evidence showing a benefit for closer comparison of hospital admissions alone.

Should the detailed data support their Tuesday announcement and support approval, Lilly and Boehringer could make more convincing arguments.

However, other companies hope to follow suit. AstraZeneca is testing its diabetes drug Farxiga, which works in the same way as Jardiance, in a study of patients with preserved ejection fraction. The study, called DELIVER, is expected to be completed in January 2022.