Novartis’s Entresto PARAGON-HF Miss Puts Large Commercial Opportunity At Risk

Entresto has narrowly failed to hit the primary endpoint in a Phase III trial in heart failure with preserved ejection fraction, a potentially lucrative indication with no approved treatments.

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Entresto: a near miss in HFpEF

Entresto, Novartis AG’s approved heart failure drug, has failed in a Phase III trial in an indication that promised to double the patient population for the product. The PARAGON-HF trial data have been keenly awaited as a key catalyst with the potential to lead to a big increase in sales and profitability of the dual-acting drug.

Entresto (sacubitril/valsartan), which is already approved to treat patients with heart failure with reduced ejection fraction (HFrEF), was being studied also for heart failure with preserved ejection fraction (HFpEF), an indication with a similar number of patients as HFrEF but with no approved treatment

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