Novartis’ CVOT and postmarket trial for Entresto likely to meet primary safety, NT-proBNP endpoints but expense will continue to curb access, experts say

20 Jul 2018

Novartis’ (VTX:NOVN) heart drug Entresto (sacubitril/valsartan) will likely lead to a reduction in cardiovascular (CV) mortality events for a successful Phase III CV outcomes trial (CVOT), experts said, despite analyst misgivings of a hypotension risk. Experts said they also expect Entresto to lead to a reduction in NT-proBNP in the postmarket PIONEER-HF study due to significant data for heart failure (HF) patients with preserved ejection fraction (HFpEF) in the Phase II PARAMOUNT trial.

While interviewed experts agreed with analyst reports that whatever the studies’ outcomes, Entresto’s high costs will continue to be a barrier to use, they dispelled analysts’ hypotension concerns for the CVOT, which is called PARAGON-HF. HF patients are on medications to maintain their blood pressure, they explained. They also said they expected reductions in CV events because of the statistically and clinically significant data for patients with reduced ejection fraction (HFrEF) from the Phase III PARADIGM-HF (NCT02226120) and Phase II PARAMOUNT (NCT00887588).

Entresto would likely be the first treatment in a decade that will be targeting HFpEF patients and if it wasn't for price barriers, could be used as their first-line of treatment, replacing generic ACE inhibitors and ARBs, said Dr Christopher Newton-Cheh, cardiologist, Massachusetts General Hospital and Harvard Medical School, Boston, and Dr Miguel Camafort-Babkowski, cardiologist, Hospital of Barcelona, Spain

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