Eli Lilly and Boehringer Ingelheim’s diabetes blockbuster Jardiance recently snagged a heart failure label expansion in the U.S. Now, the drug is widening its cardiovascular reach into Europe, with a nod that could help the med play catch-up with AstraZeneca’s SGLT2 rival Farxiga.
With a European Commission approval in the books, Jardiance is now the first SGLT2 med cleared in Europeto treat all adults with symptomatic chronic heart failure, Boehringer Ingelheim said Monday. Specifically, the drug can now be used in patients with heart failure with preserved ejection fraction (HFpEF), building on last year’s EU nod for heart failure with reduced ejection fraction (HFrEF).
Roughly half of the more than 15 million heart failure patients in Europe struggle with HFpEF, Boehringer Ingelheim said in a release. HFpEF has been characterized as “the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes and the absence of treatment options until now,” Boehringer said.
There are more than 60 million people living with heart failure globally, Neil Johnson, executive director of the Global Heart Hub, added in a statement.
For patients with HFrEF, the heart muscle doesn’t contract properly, while in patients with HFpEF, the muscle contracts properly, but the ventricles don’t relax. Both conditions affect the heart’s ability to pump enough blood.
Jardiance’s EU nod comes just a few weeks after the drug bagged an FDA approval to curb the risk of cardiovascular death and hospitalization in adults with heart failure regardless of the patient’s left ventricular ejection fraction status.
The European Commission based its decision on results from Jardiance’s late-stage EMPEROR-Preserved study, which showed the drug slashed the risk of cardiovascular death or hospitalization for heart failure by 21%. The drug’s benefit was seen regardless of patients’ ejection fraction or diabetes status, Boehringer pointed out.
Jardiance’s label expansion should give the drug an edge against AstraZeneca’s entrenched SGLT2 rival Farxiga, known as Forxiga in Europe, which beat Jardiance to the cardiovascular punch back in 2020. In November of that year, Farxiga became the first drug in its class to nab a heart failure approval, with clearance to treat HFrEF patients with and without Type 2 diabetes.
Jardiance, meanwhile, won its European HFrEF nod in June 2021.
As of the middle of 2021, Jardiance sales had climbed 17.2% to 1.4 billion euros ($1.53 billion), Boehringer Ingelheim said in a half-year earnings report published in August. In the U.S., Eli Lilly tallied Jardiance sales of $1.49 billion for the full year.