Amid impressive growth, Novartis blockbuster Entresto fails post-heart attack lawsuit


Novartis is banking on a larger label to expand the reach of its blockbuster heart med Entresto, but in patients who have suffered from heart attacks in the past, the drug has just seen a setback.

In the Phase 3 Paradise-MI trial, Entresto missed its primary endpoint for reducing the risk of cardiovascular death and heart failure after acute myocardial infarction, Novartis quietly revealed in its first quarter income statement. In the study, “digital trends have always favored” the drug over ramipril standard of care, but Entresto fell short of its target. Novartis says it “will continue to assess the data”.

“In light of the results, we are conducting further analysis to fully understand the data in the context of Entresto’s clinical profile,” a Novartis spokesperson said via email. The company plans to roll out its first results at the 70th Annual Scientific Session of the American College of Cardiology on May 15.

Novartis launched the Paradise-MI study in 2016 to see if Entresto could overtake ramipril, a widely used ACE inhibitor, to reduce cardiovascular mortality and heart failure after a heart attack. The company aims to position Entresto as an option for the 800,000 patients in the United States – and the approximately 7 million patients worldwide – who suffer from these heart attacks each year. About one in four of those 7 million people will go on to develop heart failure.

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The study of 5669 subjects compared 200 mg of Entresto to a dose of 5 mg of ramipril. Both drugs were given twice a day in addition to the standard post-heart attack treatment.

Meanwhile, on the sales front, the drug performed impressively in the first quarter. Sales of the drug jumped 39% to $ 789 million, helping Novartis offset problems in its generics business.

Entresto’s trial setback comes shortly after a major victory for Entresto in its indication of heart failure. In February, the FDA cleared the heart failure drug with preserved ejection fraction (HFpEF) for patients with lower than normal left ventricular ejection fraction (LVEF).

In addition to Entresto’s existing nod in patients with chronic heart failure and reduced ejection fraction, this approval positioned the drug as the first and only drug permitted under both conditions. The new label also paved the way for Novartis to target around 5 million of the 6 million Americans diagnosed with chronic heart failure, the company said.

Some 2 million patients with below-normal LVEF “previously had no approved treatment beyond symptom relief and management of comorbidities,” a Novartis spokesperson told Fierce Pharma in February. The company said it would act quickly to raise the profile of the drug, with plans to “immediately” deploy a representative to the field for discussions with doctors.

RELATED: Novartis’ Heart Failure Drug Entresto Wins FDA Panel Support for Larger Patient Pool – But By How Much?

The indication could increase Entresto’s peak sales estimate to $ 1 billion, Jefferies analyst Peter Welford wrote to customers last year when an independent panel from the FDA backed the drug in HFpEF. Regarding the failed trial, Welford noted that heart attack patients only accounted for $ 525 million of the $ 5.1 billion global peak sales that Jefferies estimated for Entresto.

With 2020 revenue of $ 2.5 billion, Entresto became Novartis’ third-largest revenue generator last year.

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