The heart failure market gets a little more crowded, as Eli Lilly and Boehringer Ingelheim score a win for Jardiance
Watch out, Farxiga: There’s another SGLT2 inhibitor approved to treat heart failure patients with reduced ejection fraction (HFrEF).
On Wednesday, Eli Lilly and Boehringer Ingelheim secured a win for Jardiance in HFrEF, a condition where the muscle of the left ventricle doesn’t pump normally. The indication accounts for more than half of heart failure patients, and the risk of death increases with each hospitalization, according to the partners.
In the Phase III EMPEROR-Reduced trial, Jardiance on top of standard of care was shown to reduce the risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25% compared to standard of care alone, Lilly and Boehringer Ingelheim said. The trial enrolled 3,730 adults with and without Type 2 diabetes who had a left ventricular fraction of 40% or less.
Cardiovascular death or hospitalization occurred in 19.4% of patients in the treatment arm, compared to 24.7% of those who received a placebo, with a p-value of less than 0.001, the companies said.
The drug will compete with Farxiga, which AstraZeneca claims was the first SGLT2 inhibitor proven to significantly reduce the risk of death and hospitalization due to heart failure. SGLT2 drugs were initially developed for diabetes, and work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.
Farxiga snagged an approval for HFrEF patients last May, based on data which showed the drug plus standard of care reduced the risk of cardiovascular death or worsening of heart failure by 26% compared to just the standard of care.
There’s also Novartis’ Entresto — a combination of neprilysin inhibitor sacubitril and angiotensin receptor II blocker valsartan — which is approved to treat not only HFrEF, but also heart failure patients with preserved ejection fraction (HFpEF), when the heart pumps normally but is too stiff to fill properly.
Entresto had a rocky road to approval, after failing to meet the primary endpoint in a Phase III trial. However, the FDA urged Novartis to pursue its application anyway, arguing the study’s design may have produced misleading results, and highlighting results from pre-specified follow-up analyses that pointed to significant benefits.
Lilly, Boehringer and AstraZeneca are all gunning for approvals in HFpEF, with the former reading out positive results for Jardiance last month. Jardiance aced the primary endpoint in a pivotal outcomes trial in heart failure patients with a preserved ejection fraction (HFpEF) with or without Type 2 diabetes, cutting the composite risk of cardiovascular death or hospitalization compared with placebo, the partners announced.
Meanwhile, AstraZeneca is currently running a more than 6,200-patient Phase III study for Farxiga in HFpEF, which is expected to wrap in early 2022.