Novartis’ star blockbuster flunks closely watched PhIII — but they may file for key add-on OK anyway
One of Novartis’ top Phase III catalysts this year has flunked its carefully calibrated late-stage test — but the pharma giant isn’t ready to abandon the program yet.
Investigators say their PARAGON-HF study of Entresto failed in heart failure with preserved ejection fraction, but only “narrowly” missed success. And while the p value isn’t provided, the pharma giant says that they plan some sit-downs with regulators to explore if they’d be open to an add-on approval — after they step back to review all of the data.
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