Lilly, Boehringer Ingelheim's Jardiance scores heart failure FDA nod, and an even bigger win could come later this year

Jardiance
In a crowded heart failure market, Jardiance is competing with Novartis' Entresto, AstraZeneca's Farxiga and Bayer and Merck's Verquvo. (Fierce Pharma)

Staying relevant in the competitive heart failure market requires contenders to keep their products moving forward.

On Wednesday, Eli Lilly and Boehringer Ingelheim did just that for Jardiance, scoring an FDA approval to treat those with heart failure with reduced ejection fraction (HFrEF) regardless of whether they have Type 2 diabetes. It is the first indication for Jardiance outside the Type 2 diabetes arena.

The endorsement also allows Jardiance to play catch-up with AstraZeneca’s Type 2 diabetes drug Farxiga, which last year became the first SGLT2 inhibitor to score an FDA green light for heart failure patients whether or not they have diabetes. 

Novartis' blockbuster Entresto is the most popular heart failure medication and can be used in combination with SGLT2 inhibitors. Another new contender for heart failure is Verquvo, a guanylate cyclase stimulator from Merck and Bayer that won its first approval in January, specifically for HFrEF patients.

HFrEF, which occurs when the heart muscle does not contract effectively and causes reduced blood flow to the body, accounts for more than half of the 60 million-plus heart failure cases worldwide. 

Jardiance's new approval comes after the drug turned in positive results in the phase 3 Emperor-Reduced trial, which recruited 3,730 HFrEF patients. The trial showed that Jardiance reduced the risk of time to death or hospitalization by 25% against placebo. Jardiance also reduced the risk of first and recurrent hospitalization by 30% and retained its safety profile from its other indications. 

“Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalization,” Mohamed Eid, the head of clinical development and medical affairs of cardio-metabolism and respiratory medicine at Boehringer-Ingelheim said in the release.

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

Looking forward, Jardiance could be poised for an even more significant win in heart failure. In July, Lilly and Boehringer Ingelheim revealed data showing Jardiance’s effectiveness in heart failure patients with preserved ejection fraction (HFpEF). The companies expect to file for regulatory approvals by the end of this year.

With that nod in hand, 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.

After that readout, market analysts at Cantor Fitzgerald warned investors not to overlook the drug's promise.

“We think the potential for Jardiance to treat cardiovascular disease could be a blockbuster opportunity that is still underappreciated,” wrote Louise Chen in a note to clients. 

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

Investigators are presenting the detailed data readout for that trial next weekend at the European Society of Cardiology's annual congress.