NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
No Result
View All Result
Home ALL Healthcare

Novartis Entresto® granted expanded indication in chronic heart failure by FDA

by Emma Jones
February 17, 2021
A A
  • Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 
  • Expanded indication enables potential treatment of more adults with left ventricular ejection fraction (LVEF) below normal, the group where benefits are most clearly evident1 
  • Of the more than 6 million Americans suffering from chronic heart failure (CHF), approximately 5 million may be appropriate for treatment with Entresto3,4

Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal1. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat1.

For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3.

“This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced. Until now, treatment for these patients was largely empiric,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF Executive Committee Co-Chair. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined HFpEF2,5,6. The greatest benefit was shown in patients with LVEF below normal6.

Approximately 6 million Americans are living with chronic heart failure (CHF)4. Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal2-4. The prevalence of heart failure (HF) is increasing as the population ages4. Patients often face worsening symptoms that result in frequent HF hospitalizations7. Each hospitalization event is associated with worsening long-term prognosis7. Approximately one in four patients are re-admitted for HF and 10 percent may die within 30 days of discharge8,9. Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a HF diagnosis4.

“We are proud of our goal to reimagine medicine. This commitment has enabled us to bring Entresto to millions more heart failure patients in the US, many of whom did not have an approved treatment option until now,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “This achievement would not have been possible without tremendous dedication from investigators, patients in our clinical trials and the advocacy community, to whom we are extremely grateful.”

About our longstanding commitment to heart failure
Our goal is to reimagine medicine for heart failure patients. Novartis established the largest global clinical program in the HF disease area across the pharma industry to date. Known as FortiHFy, it is comprised of more than 40 clinical studies designed to generate an array of additional data on efficacy, quality of life, patient-reported outcomes and real-world evidence with Entresto, as well as to extend understanding of heart failure. FortiHFy includes trials across the spectrum of heart failure, such as PARADIGM-HF, PIONEER-HF, TRANSITION, PROVE-HF, PARAGON-HF and PARAMOUNT. Worldwide, it is estimated that more than 30,000 patients have participated in the Entresto clinical trials program, and it is estimated that more than 2.8 million patients are on treatment with Entresto today.

Tags: < Market
ShareTweetShareSend

Related Industries

Healthcare

Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

January 26, 2023
Healthcare

Johnson & Johnson Reports Q4 and Full-Year 2022 Results

January 25, 2023
Healthcare

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

January 18, 2023
Healthcare

AbbVie and Anima Biotech Announce Collaboration for the Discovery and Development of mRNA Biology Modulators against Oncology and Immunology Targets

January 11, 2023
Healthcare

Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders

January 7, 2023
Healthcare

Michelle Quinn Named Acting General Counsel for BD

January 7, 2023

Microsoft and Viasat announce new partnership to deliver internet access to underserved communities globally

January 15, 2023

...

IHG Hotels & Resorts Donates $500,000 to AHLA Foundation Human Trafficking Survivor Fund

January 25, 2023

...

Ford’s John Savona to Retire in March, Closing 33-Year Career; Bryce Currie Will Lead Americas Manufacturing, Labor Affairs

January 12, 2023

...

Don Bailey Joins AIG as Global Head of Distribution and Field Operations

January 4, 2023

...

KKR Appoints Tim Lawler as Executive Advisor

January 18, 2023

...

Mercedes-Benz to launch global branded high-power charging network, starting in North America

January 6, 2023

...

Cargill Wins 2023 BIG Innovation Award

January 12, 2023

...

Mark Parker To Be Named Chairman Of The Walt Disney Company

January 12, 2023

...

Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders

January 7, 2023

...

NORTH AMERICAN BUSINESS (www.na-biz.com) is a leading source of business and corporate news, information, industry trends, market updates and insights across a broad spectrum of industries in North America and worldwide.

INDUSTRIES

  • Aero
  • Agriculture
  • ALL
  • Automotive
  • Business Service
  • Chemical
  • Construction
  • Construction Materials
  • Consumer
  • Education
  • Energy
  • Entertainment
  • Environmental
  • F&B
  • Financial
  • Healthcare
  • Hospitality
  • Industrial
  • IT
  • IT Hardware
  • Logistic
  • Metal & Mining
  • Packaging & Paper
  • Rail
  • Real Estate
  • Telecom

CONTACT US

EDITORIAL:     editor#na-biz.com

PARTNERSHIP:     biz#na-biz.com

HUMAN RESOURCE:     hr#na-biz.com

* (replace # with @)

  • Official Site

Copyright © NA-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © NA-BIZ.COM All rights reserved.