Eli Lilly, Boehringer Ingelheim's Jardiance posts 'blockbuster' heart failure win, setting up 2021 filings

Jardiance
Eli Lilly and Boehringer Ingelheim's Jardiance has been shown to reduce death and hospitalizations in heart failure patients, regardless of their form of the disease. (Fierce Pharma)

In an increasingly crowded heart failure field, Novartis’ Entresto is the undisputed leader, AstraZeneca’s Farxiga is the up-and-coming challenger and Merck and Bayer’s Verquvo is the dark horse contender.

But with pivotal trial win on Tuesday, Lilly and Boehringer Ingelheim's Jardiance can claim an important edge.

Eli Lilly and Boehringer Ingelheim’s Type 2 diabetes med Jardiance has been shown to reduce the risk of death and hospitalization from heart failure in patients with preserved ejection fraction (HFpEF). If approved, Jardiance would become the only therapy to improve outcomes in all heart failure patients, regardless of ejection fraction status or whether they have Type 2 diabetes.

Market analysts at Cantor Fitzgerald warned investors not to overlook the news as it might be an indicator of big things to come for the med.

"We think the positive readout is good news for Lilly and we think the potential for Jardiance to treat cardiovascular disease could be a blockbuster opportunity that is still underappreciated," analyst Louise Chen wrote to clients.

The trial win was a “significant breakthrough in cardiovascular medicine" and represents a "new hope for people with HFpEF," principal study investigator Stefan Anker, a heart failure cardiologist at Charite Berlin, Germany, said in a release.

RELATED: Lilly, Boehringer—following AZ—nab Jardiance win in heart failure patients with or without diabetes

The condition, called by Anker “the most challenging form of heart failure to treat,” affects roughly half of the 60 million heart failure patients in the world and is increasing rapidly in the western world.

Lilly and Boehringer Ingelheim will present the detailed findings at the European Society of Cardiology Congress on Aug. 27. The pair plans to file for regulatory approvals by the end of the year.

In recent years, pharma companies have been making strides in treating various types of patients with heart failure.

In February, Entresto won an FDA nod for chronic heart failure with preserved ejection fraction for patients whose left ventricular ejection fraction is below normal. The label expansion made Entresto, already with an approval for patients with reduced ejection fraction (HFrEF), the first drug with clearance in both indications.

RELATED: Novartis’ blockbuster heart med Entresto snags FDA approval in larger patient group

Before that, Merck and Bayer in January scored approval for Verquvo to treat certain HFrEF patients. That green light is limited to high-risk patients who’ve recently been hospitalized or received diuretics as outpatients for acute decompensated heart failure. 

And in May of last year, SGLT2 rival AstraZeneca beat Lilly and Boehringer to the punch, winning an FDA nod for Farxiga in HFrEF patients with or without Type 2 diabetes. 

Despite the competition, Jardiance could be on the verge of a much more sweeping approval.

“Jardiance was the first SGLT2 inhibitor to reduce cardiovascular death for people with Type 2 diabetes and cardiovascular disease and we now have reached another important milestone,” said Jeff Emmick, M.D., the head of product development at Lilly.