LONDON, May 23 (APM) - Novartis received a boost for its new heart failure drug Entresto after it was recommended ahead of older therapies in global guidance.
The company said on Saturday that Entresto (sacubitril+valsartan) has been given a class I recommendation in clinical practice guidelines released by the American College of Cardiology, the American Heart Association and the Heart Failure Society of America in the U.S., and the European Society of Cardiology in the EU.
Class I recommendation is the strongest endorsement for a drug from these cardiology bodies, said Novartis in a statement, making the drug the standard therapy for heart failure with reduced ejection fraction (HFrEF) ahead of cheaper ACE inhibitors and angiotensin II receptor blockers.
The guidelines also call for doctors to switch HFrEF patients with mild to moderate symptoms from ACEs or ARBs to Entresto, said Novartis.
The recommendation should go some way to improving the fortunes of Entresto, which has struggled to make an impact since its approval last year
Speaking at the start of the year, Novartis' head of pharmaceuticals David Epstein said that with a 2015 turnover of $21 million, the product has been slower to get off the ground than expected, which he put down to "limited" reimbursement in the U.S. until December (APMMA 46095).
The Swiss company has taken some steps to address this, including the launch last week a major clinical programme to develop evidence to support the use of the drug, including several comparison studies with other treatments (APMMA 47919).
The new global guidelines are based on data from the PARADIGM-HF trial, which showed Entresto significantly reduced deaths from cardiovascular causes and heart failure hospitalisations in patients with HFrEF.
Vas Narasimhan, global head of development and chief medical officer for Novartis, welcomed the "swift and broad" recommendation, which redefine the standard of care in heart failure.
"We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalisation or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies," said Narasimhan.
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