New global guidelines on the treatment of heart failure strongly endorse the use of Novartis’ Entresto, boosting the prospects for a drug that has struggled to gain traction since its launch last year.
U.S. and European heart experts gave the highest “class 1” recommendation to Entresto for use in patients with heart failure, a debilitating condition in which the heart is unable to pump enough blood around the body.
The guidance in the key U.S. market says that Entresto should replace two older types of drugs known as ACE inhibitors and ARBs in heart failure patients who have adequate blood pressure and tolerance to standard drugs.
In Europe, doctors are recommended to switch their patients to the medicine if they fit the profile of a 2014 clinical trial that proved Entresto was better than standard treatment.
“The guidelines read favourably. In fact, they are about as favourable as we could have hoped for,” said Bernstein analyst Tim Anderson.
Given Entresto’s sluggish sales, investors were watching carefully to see what the guidelines said and when they would be issued, since this will influence prescribers. There had been concerns the announcements could be staggered and might only recommend limited use.
In the event, the American College of Cardiology, the American Heart Association and the European Society of Cardiology said they issued their guidelines simultaneously to “unify the message, minimize confusion, and improve and standardize the care of patients”.
Novartis said the new guidance, published late on Friday, would redefine the standard of care for treating reduced ejection fraction 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 Vas Narasimhan, chief medical officer for Novartis.
The guidelines do contain some expected caveats, with experts saying that Entresto should not be given together with an ACE inhibitor or used in patients with a history of a swelling condition known as angioedema.
Experts also gave a “class IIa” recommendation to Amgen’s new drug Corlanor for use on top of beta blockers for certain heart failure patients who have a resting heart rate of at least 70 beats per minute. Servier sells the product outside the United States.
There have been few new drugs for heart failure and Novartis has touted Entresto as an eventual $5 billion-a-year seller.
Yet first-quarter sales of the medicine were just $17 million and Novartis now predicts 2016 sales of a modest $200 million, well below initial analyst forecasts.
The lack of specific guidelines from professional bodies until now will have contributed to reticence among some doctors to prescribe Entresto – but cost is also an issue. With a price tag of around $4,500 a year, some physicians worry that patients might quit their medication.
Novartis on Thursday unveiled a battery of new clinical trials for Entresto designed to boost confidence in the drug and assuage doctors’ concerns over switching patients to Entresto when they are stable on older medicines.