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May 12, 2021

LoA Update: Novartis’ approval likelihood for Entresto plummets by 11 points in acute myocardial infarction due to negative Phase III data

Novartis’ Entresto’s (sacubitril/valsartan) Likelihood of Approval (LoA) in acute myocardial infarction dropped by 11 points on the heels of the Phase III PARADISE-MI trial not meeting its primary endpoint.

By Reynald Castañeda

Novartis’ Entresto’s (sacubitril/valsartan) Likelihood of Approval (LoA) in acute myocardial infarction dropped by 11 points on the heels of the Phase III PARADISE-MI trial not meeting its primary endpoint.

Entresto’s LoA dropped to 18% from 29%, as determined on 7 May, by GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. In PARADISE-MI, Entresto did not meet the primary composite endpoint of reducing risk of cardiovascular death and heart failure events after an acute myocardial infarction, despite there being a trend favouring Entresto against standard-of-care generic ramipril, according to a 27 April media release detailing company guidance for the year.

Topline PARADISE-MI data will be presented on 15 May as a late-breaking abstract at the Virtual American College of Cardiology’s Annual Scientific Session.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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