Dive Brief:
- The latest Entresto data showed that starting the Novartis drug in the hospital for heart failure patients has better outcomes than using enalapril, the established treatment.
- In the PIONEER-HF study, patients on Entresto saw a key biomarker of severity and prognosis cut by almost 30% compared with those on enalapril. Significant reductions in NT-proBNP — a hormone released upon pressure changes inside the heart — were seen as early as a week after starting Entresto.
- Following eight weeks of treatment, patients taking the Novartis drug versus those taking enalapril experienced a 46% reduction in a composite of risk that included being re-hospitalized for heart failure; needing a left ventricular assist device (LVAD) insertion; getting listed for cardiac transplantation; and death.
Dive Insight:
Novartis' clinical programs for Entresto (sacubitril and valsartan), including PIONEER and TRANSITION, have been building up scores of data over the last few years. With PIONEER-HF, the Swiss pharma giant believes it now has the evidence needed to support Entresto becoming the foundational therapy for heart failure patients with reduced ejection fraction — a population at high risk of death and hospital readmission.
"Through the Entresto scientific program, we are reimagining the standard of care for HFrEF patients and the use of Entresto as foundation therapy," said Shreeram Aradhye, chief medical officer of Novartis Pharmaceuticals, in a Nov. 11 statement.
Results were presented at the American Heart Association's meeting over the weekend and published in the New England Journal of Medicine.
Novartis picked up initial approval for Entresto in the U.S. in July 2015 and in the EU several months later. It would the gain Class 1 recommendations in both geographies in 2016.
The drug's sales are growing fast, with the worldwide total increasing more than 100% year over year in the third quarter to $271 million.
There is still more data to come. The PARAGON study is ongoing, evaluating patients with preserved ejection fraction, with results expected in mid-2019. And the PARADISE study, which is testing Entresto in pre-heart failure, post-heart attack patients, is enrolling according to plan.
"Overall, the Entresto picture is looking strong, and we continue to see solid momentum around the world with this medicine," said Novartis CEO Vas Narasimhan on the company's third quarter call.