FDA approves new heart failure pill from Novartis

David Epstein, the company’s head of pharmaceuticals, told Reuters last week he was talking to healthcare customers about a system under which they would get the drug at a discount, but then pay Novartis more if, as expected, it successfully reduces the need for costly hospital visits.

The FDA’s decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.

Novartis has already predicted that Entresto can potentially achieve more than $5 billion in annual sales globally, making it one of the world’s best-selling medications. This has been considered as an unusual move by the company. Shortness of breath, fatigue, and retention of fluids are typically the symptoms that lead to hospitalization.

Entresto was named LCZ696 during its development, and scientists believe it could replace what are known as angiotensin-converting enzym (ACE) inhibitors, which are now used in the treatment of heart failure.

Mr. Epstein said the price was “really quite reasonable”, given that some drugs for other diseases cost many times that amount and confer less benefit.

Of the six million people in the USA diagnosed with heart failure, at least half could be candidates for Entresto, which “may fundamentally change their lives for the better”, Yancy said.

Heart failure is the condition where a heart of the patient has lost part of its pumping capacity and can deteriorate into a situation where the patient has difficulty breathing which could be followed by a trip to the emergency room.

Novartis said it would immediately begin shipments of Entresto in the US.

Entresto will be competing with other very cheap – though less effective – pills and Novartis has warned initial uptake may be slow.

In the clinical trial that was so successful, about 8,400 participants were randomly assigned to take either Entresto or an ACE inhibitor called enalapril. The patient would take two tablets each day. That’s a difference of 20 percent. The agency approved another heart failure from Amgen Inc.in April.

The main side effects for Entresto would be impairment of the kidney, low blood pressure, and high potassium levels. Some patients also experienced an allergic reaction that causes swelling of the face or lips. Blacks and those with a previous history of the condition were at increased risk, it said.

Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization.