With one heart failure nod already in hand, Eli Lilly and Boehringer Ingelheim’s diabetes med Jardiance is angling to quickly land a second.
The companies Friday rolled out full results on the SGLT2 inhibitor’s ability to help patients with heart failure with preserved ejection fraction (HFpEF). The data, delivered at the annual meeting of the European Society of Cardiology (ESC), bode well for a planned regulatory filing later this year.
In a trial called EMPEROR-Preserved, Jardiance cut the combined risk of cardiovascular death or hospitalization from heart failure in HFpEF patients with or without diabetes. At the 26-month mark, 13.8% of Jardiance patients died from cardiovascular causes or were hospitalized because of their heart failure versus 17.1% of placebo patients. Jardiance's success at keeping patients out of the hospital drove the overall win on the composite score, investigators said.
An HFpEF nod would distinguish Jardiance as the only med to improve outcomes in all heart failure patients, no matter their ejection fraction status or whether they have Type 2 diabetes. It would also help set the drug apart in a field where AstraZeneca’s Farxiga, Novartis' Entresto and Merck and Bayer’s Verquvo are already jockeying for space.
While symptoms may look similar between HFpEF and heart failure with reduced ejection fraction (HFrEF)—where Jardiance bagged an approval earlier this month—the diseases are quite different. Just because a drug is shown to work in reduced ejection fraction doesn’t mean it will help in preserved, Mohamed Eid, M.D., head of cardiometabolism and respiratory medicine clinical development and medical affairs at Boehringer Ingelheim, said in an interview.
“This is the uniqueness of the breakthrough that we’re dealing with with a preserved ejection fraction,” he said, adding that the drug’s recent win in its HFpEF phase 3 trial EMPEROR-Preserved “offers the potential for Jardiance to be a very important therapy for people with heart failure, regardless of their ejection fraction status.”
For patients with HFrEF, the heart muscle doesn’t contract properly, while in HFpEF, the muscle contracts correctly, but the ventricles don’t relax. Both conditions affect the heart’s ability to pump enough blood.
The EMPEROR-Preserved results were consistent across the study's subgroups, including patients with or without diabetes and people whose left ventricular ejection fraction was less than 50%, 50% to less than 60% or 60% or more.
The companies are also debuting pooled results from EMPEROR-Preserved and EMPEROR-Reduced at ESC, which they’re using to tout Jardiance’s potential “across the spectrum of heart,” Eid said.
Looking at the two studies together, Jardiance reduced the risk of heart failure hospitalization by about 30% in patients with preserved and reduced ejection fractions.
The two studies are looking at a “very broad range of different types of adults living with heart failure,” Eid said. The breadth of the study doesn’t just include ejection fraction status, but also spans patients with a variety of other health problems.
Jardiance in August broke out of its Type 2 diabetes niche with an approval to treat HFrEF in patients with or without Type 2 diabetes. The nod came a little over a year after AstraZeneca’s rival SGLT2 drug, Farxiga, nabbed its own HFrEF green light.
It's a newly crowded field: Merck and Bayer’s Verquvo won approval in January to treat certain high-risk HFrEF patients.
Meanwhile, Novartis’ Entresto—which holds claim to the heart failure crown—won a preserved ejection fraction nod in February in patients whose left ventricular ejection fraction is lower than normal. The drug’s new label made it the first cleared to treat patients with both HFrEF and HFpEF, though Jardiance is pursuing a broader approval in patients with preserved ejection fraction.
Plus, another challenger materialized at ESC in the form of Lexicon Pharmaceuticals’ dual SGLT1 and SGLT2 inhibitor sotagliflozin. Already approved in Type 1 diabetes, the drug made its case this week to push into Type 2 disease patients with heart failure.