Novartis' (NVS) Entresto Gets FDA Panel Nod for Expanded Use
Novartis NVS announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto (sacubitril/valsartan) in the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
Shares of the company have decreased 2.7% year to date against the industry’s growth of 5.4%.
The committee's positive decision was based on the data supporting the benefit of Entresto in reducing worsening heart failure in patients studied in the PARAGON-HF study. The data from the study showed a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in heart failure with reduced ejection fraction (HFrEF), and aclinical benefit of the drug in HFpEF patients.
The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021. If approved by the agency, Entresto could become the first therapy indicated for the treatment of patients with both major types of chronic heart failure — HFpEF andHFrEF — and the only chronic heart failure treatment studied in both conditions against active comparators.
HFpEF patients currently have no approved treatment options and face worsening symptoms that result in frequent HF hospitalizations, emergency room and urgent office visits.
Notably, Entresto is approved in the United States for the treatment of HF in patients with systolic dysfunction.
Novartis AG Price
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Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. ARPO, Aptose Biosciences Inc. APTO and Alimera Sciences Inc. ALIM, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.
Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.
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