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.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’