In the rush for differentiation in an increasingly competitive heart failure (HF) field, AstraZeneca can now make a singular claim. Its SGLT2 inhibitor Farxiga is the first HF drug to demonstrate that it reduces the risk of death in patients regardless of their left ventricle ejection fraction (LVEF) range, the company said.
The conclusion comes from pooled data in two phase 3 trials of more than 11,000 HF patients. The data analysis showed that Farxiga reduced the risk of cardiovascular death by 14%, the risk of death by any cause by 10% and the risk of hospitalization for HF by 29% irrespective of patients' LVEF range.
The data set Farxiga up to become the second SGLT2 inhibitor, along with Boehringer Ingelheim’s Jardiance, to be approved for the two major types of HF. Novartis’ angiotensin receptor neprilysin drug Entresto also has nods in both indications.
In 2020, Farxiga won an FDA approval for patients with reduced ejection fraction, which accounts for roughly half of those with HF. Now, an approval for the other half of the HF population is possible.
“Heart failure patients with LVEF greater than 40% are the most difficult to treat with few treatment options available to them,” AZ's R&D chief Mene Pangalos said in a statement.
Investigators presented the findings Saturday in Spain at the European Society of Cardiology’s annual event.
HF is a growing problem, especially in the U.S. where the population is aging. In 2030, it is expected that there will be 8 million cases in the U.S.
For patients with reduced ejection fraction (HFrEF), the heart muscle doesn’t contract properly. For patients with preserved ejection fraction (HFpEF), the muscle contracts properly but the ventricles don’t relax. Both conditions cause diminished blood flow.
AZ also presented results from one of the trials in the pooled analysis, the phase 3 DELIVER study, which showed that Farxiga reduced the risk of hospitalization and death from a cardiovascular event by 18% in those with mildly reduced or preserved ejection fraction.
Farxiga won its original FDA nod to treat Type 2 diabetes in 2014. Since then, SGLT2 inhibitors have proven effective in patients with kidney and heart disease. In 2019, the FDA expanded Farxiga’s label to prevent HF in those with Type 2 diabetes.
While Farxiga’s sales trail those of Jardiance and Entresto, they are growing quickly. In 2021, they reached (PDF) $3 billon, a 53% increase from 2020. Then, in the first half of this year, Farxiga generated (PDF) $2.1 billion for a 55% increase compared with the same period of last year.
Last year, Merck and Bayer’s Verquvo became the first soluble guanylate cyclase (sGC) drug to be sanctioned for HF. Its indication is for HFrEF.