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Novartis builds blockbuster case for Entresto, beating out a cheap ACE inhibitor — or not

Novartis execs got the positive data they were looking for from their PIONEER-HF study of Entresto to back accelerating sales of the heart medication.

Initially a slow moving product hampered by physicians reluctant to adopt a new med and payers who were none too happy with the price, Entresto is now comfortably hitting its blockbuster stride. In the third quarter the drug earned $271 million. And now they’ll be looking for continued acceleration after the drug scored the primary endpoint and key survival and re-hospitalization numbers in a head-to-head study with the cheap ACE inhibitor enalapril.

Shreeram Aradhye

Researchers compared the two drugs among patients suffering from heart failure with reduced ejection fraction. And they came away with significantly better results for a key biomarker — NT-proBNP — at weeks 4 and 8. There was also a “46% reduction in the risk of a composite of death, heart failure re-hospitalization (hospital stay >24 hours), requirement for left ventricular assist device (LVAD) insertion or listing for cardiac transplantation compared to enalapril over 8 weeks.”

But the trial results also spurred some Twitter discussion about the doses used in the trial.

That point was overlooked by the investigators involved.

Eric Velazquez

“With the PIONEER-HF trial results — once acute heart failure is diagnosed, patients are hemodynamically stabilized, and a low ejection fraction is confirmed — sacubitril/valsartan should be started promptly to reduce neurohormonal activation and reduce the risk of post-discharge heart failure hospitalization,” noted Yale’s Eric Velazquez.

The trial also builds on Novartis’ ambitious trial strategy, aiming to build their argument to get this drug to patients at an earlier point.

Novartis CMO Shreeram Aradhye put it this way:

Together with data from the PARADIGM-HF study, which demonstrated the superior benefit of Entresto compared to an ACEi on cardiovascular mortality and HF hospitalizations in ambulatory patients, there is now consistent evidence in the in- and outpatient settings supporting the use of Entresto.


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