Novartis has released new data for its heart failure treatment Entresto which could help convince doctors and payers of the drug’s value.
Entresto is currently approved in Europe for the treatment of symptomatic chronic heart failure with reduced ejection fraction. In the US it is indicated for the treatment of heart failure in patients with systolic dysfunction.
New results from PIONEER-HF, which saw Entresto outperform angiotensin-converting enzyme (ACE) inhibitor enalapril, a commonly-used heart failure medicine.
PIONEER-HF is a pre-specified exploratory analysis of the effects of Entresto compared to enalapril, and was studied within heart failure patients with reduced ejection fraction (HFrEF).
In that study Entresto delivered significantly greater (29%) and more rapid reductions in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP), an established biomarker for heart failure severity and prognosis.
Most importantly, the drug had some clear benefits in terms of outcomes: it produced a 46% reduction in serious clinical outcomes, reducing death and heart failure re-hospitalisation compared to enalapril.
Heart failure patients with reduced ejection fraction (HFrEF) often becomes subject to recurrent hospital admittance for an acute decompensation event, for which there is a high risk of death.
Entresto, administered twice-daily tablet reduces the strain on the failing heart and enhancing the natriuretic peptide system.
It does this by inhibiting harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS), a pathologic consequence of ill cardiac function.
Other heart failure medicines, including enalapril, only block the damaging effects of the overactive RAAS and don’t help to boost protective neurohormonal systems, unlike Entresto.
“PIONEER-HF further confirmed the safety and benefit, as reflected in the reduction of an important biomarker, of in-hospital initiation of Entresto treatment in HFrEF patients stabilised following ADHF,” said Shreeram Aradhye, chief medical officer and global head, medical affairs at Novartis.
“Together with data from the PARADIGM-HF study, which demonstrated the superior benefit of Entresto compared to an ACEi on cardiovascular mortality and HF hospitalisations in ambulatory patients, there is now consistent evidence in the in and outpatient settings supporting the use of Entresto. Through the Entresto scientific programme, we are reimagining the standard of care for HFrEF patients and the use of Entresto as foundation therapy.”
Though the results are hardly surprising considering Entresto was discovered as the first chronic heart failure therapy to show an improvement over ACE inhibitors.
However, Entresto has underperformed against expectations since its launch in 2015. The latest market data from Q3 showed the drug achieved $271m compared to the same period last year, and putting it on course to break through the $1bn annual earnings mark by the end of this year.
The company says the HFrEF data is seeing its initiation grow in hospital in-patients, but it envisages its increasing use in out-patients to help control the condition and prevent it from developing into the acute decompensated heart failure (ADHF).
The drug also has the potential to be the first approved treatment for another variant of the condition, Heart Failure with a Normal Ejection Fraction (HFpEF), which affects around 50% of heart failure patients. The company has a large-scale trial PARAGON-HF, which will produce results in 2019.