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Investegate |NOVARTIS AG CHF0.50(REGD) Announcements | NOVARTIS AG CHF0.50(REGD): Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF


NOVARTIS AG CHF0.50(REGD)
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)
Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators ....

New York , United States , Eric Althoff , Isabella Zinck , David Soergel , Thomas Hungerbuehler , Coll Cardiol , Samir Shah , Scott Solomon , Sloan Simpson , Phil Mcnamara , American Heart Association , Committee Co , Advisory Committee , Novartis External Communications , Metabolic Drug Development , Metabolism Communications , Us Department Of Health , Human Services , Renal Drugs Advisory Committee , Drug Administration , Professor Of Medicine At Harvard Medical School , Novartis Us External Communications , Exchange Commission , Novartis Pharmaceuticals Corp , Hf New York Heart Association ,

Novartis International AG: Novartis announces positive FDA Advisory Committee recommendation for use of Entresto to treat patients with HFpEF


(2)
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)
Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators
1,2
HFpEF patients currently have no approved treatment options and face worsening symptoms that result in frequent HF hospitalizations, emergency room and urgent office visits
1,3,4
Basel, December 16, 2020 - Novartis today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto ....

New York , United States , Eric Althoff , Isabella Zinck , David Soergel , Thomas Hungerbuehler , Coll Cardiol , Samir Shah , Scott Solomon , Sloan Simpson , Phil Mcnamara , American Heart Association , Committee Co , Novartis External Communications , Metabolic Drug Development , Metabolism Communications , Us Department Of Health , Human Services , Renal Drugs Advisory Committee , Drug Administration , Professor Of Medicine At Harvard Medical School , Novartis Us External Communications , Exchange Commission , Novartis Pharmaceuticals Corp , Hf New York Heart Association , New Drug Application ,

Novartis announces positive FDA Advisory Committee recommendation for use of Entresto to treat patients with HFpEF


Posted December 16th, 2020 for Novartis
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)
Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of chronic heart failure: HFpEF and HFrEF; and the only chronic heart failure treatment studied in both conditions against active comparators
1,2
HFpEF patients currently have no approved treatment options and face worsening symptoms that result in frequent HF hospitalizations, emergency room and urgent office visits
1,3,4
Basel, December 16, 2020 Novartis today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto ....

New York , United States , Coll Cardiol , David Soergel , Scott Solomon , American Heart Association , Committee Co , Renal Drugs Advisory Committee , Human Services , Drug Administration , Professor Of Medicine At Harvard Medical School , Metabolic Drug Development , Exchange Commission , Us Department Of Health , Novartis Pharmaceuticals Corp , Hf New York Heart Association , New Drug Application , Harvard Medical School , Global Head , New York Heart Association , Drug Evaluation , Biologics Evaluation , Englj Med , American Heart , Rev Cardiol , Social Activity Limitations ,