May 21, 2016
New global guidelines on the treatment of heart failure 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 said on Friday 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.
However, Entresto should not be given together with an ACE inhibitor or used in patients with a history of fluid build-up, they said.
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".
The guidelines also said Amgen's new drug Corlanor may be beneficial when given on top of beta blockers for certain heart failure patients who have a resting heart rate of at least 70 beats per minute.
There have been few new drugs for heart failure - a debilitating condition in which the heart is unable to pump enough blood around the body - and Novartis has touted Entresto as an eventual $5 billion-a-year seller.
Entresto was hailed as a major advance in treatment after a pivotal clinical trial in 2014 found it significantly reduced the risk of cardiovascular death compared to a standard ACE inhibitor.
Yet first-quarter sales of the medicine were just $17 million and Novartis now predicts 2016 sales of a modest $200 million, well below earlier analyst forecasts.
The lack of specific guidelines from professional bodies until now may 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.
(Reporting by Ben Hirschler; Editing by Hugh Lawson)