Entresto Label: Strong Efficacy, Complex Dosing
PARADIGM-HF study shows 20% reduced risk of CV death and heart failure hospitalization compared to ACE inhibitor enalapril.
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Cardiovascular and Renal Drugs Advisory Committee will consider whether exploratory analyses from the PARAGON-HF trial, which narrowly missed its primary endpoint, plus demonstrated efficacy in an adjacent indication, support a new claim for heart failure patients with preserved ejection fraction.
What caused Novartis's innovative heart failure drug to falter, missing sales targets by $30m in 2016, and how is it expected to bounce back in 2017? Scrip explores Entresto's journey and what this experience shows about the changing face of pharma's customers.
In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.