* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Friday, August 29, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    ‘Netflix House’ entertainment complexes are coming. Here’s when they open – Los Angeles Times

    Exciting News: Netflix’s House Entertainment Complexes Are Opening Soon!

    ‘Big Brother’s’ Rylie Jeffries Finally Speaks Out on Katherine Woodman Controversy – El Paso Inc.

    Big Brother’s Rylie Jeffries Finally Speaks Out on Katherine Woodman Controversy

    ‘SNL’ Parts Ways With Emil Wakim Amid Rumored Season 51 Cast Shakeup – yahoo.com

    SNL Shakes Up Season 51 Cast with Emil Wakim’s Surprising Exit

    Do you have a favorable or an unfavorable opinion of Taylor Swift? – YouGov

    Do You Love Taylor Swift or Not? Share Your Thoughts!

    Upload Season 4 Review – yahoo.com

    Upload Season 4 Review: A Thrilling New Chapter Unveiled

    ‘The Roses’ review: Olivia Colman, Benedict Cumberbatch sparkle in dark comedy – Yakima Herald-Republic

    The Roses’ Review: Olivia Colman and Benedict Cumberbatch Shine in Dark Comedy Delight

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Japan’s legacy LCD and chip technology find new home in India – Nikkei Asia

    How Japan’s Breakthrough LCD and Chip Technologies Are Driving Innovation in India

    ITSWC 2025: Thursday sessions guide – Traffic Technology Today

    Your Ultimate Guide to Thursday Sessions at ITSWC 2025

    MC Machinery Technology Summit Showcases Manufacturing Innovations – Modern Machine Shop

    MC Machinery Technology Summit Unveils Cutting-Edge Manufacturing Innovations

    US-ROK Technology Cooperation Faces Rising Tensions – The National Interest

    Rising Tensions Put US-South Korea Technology Partnership to the Test

    The Role of AI and Technology in Shaping the Future of Interactive Entertainment – Technology Org

    How AI and Technology Are Transforming the Future of Interactive Entertainment

    Ten upcoming sports stadiums where technology takes to the field – Dezeen

    10 Futuristic Sports Stadiums Revolutionizing the Game with Cutting-Edge Technology

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    ‘Netflix House’ entertainment complexes are coming. Here’s when they open – Los Angeles Times

    Exciting News: Netflix’s House Entertainment Complexes Are Opening Soon!

    ‘Big Brother’s’ Rylie Jeffries Finally Speaks Out on Katherine Woodman Controversy – El Paso Inc.

    Big Brother’s Rylie Jeffries Finally Speaks Out on Katherine Woodman Controversy

    ‘SNL’ Parts Ways With Emil Wakim Amid Rumored Season 51 Cast Shakeup – yahoo.com

    SNL Shakes Up Season 51 Cast with Emil Wakim’s Surprising Exit

    Do you have a favorable or an unfavorable opinion of Taylor Swift? – YouGov

    Do You Love Taylor Swift or Not? Share Your Thoughts!

    Upload Season 4 Review – yahoo.com

    Upload Season 4 Review: A Thrilling New Chapter Unveiled

    ‘The Roses’ review: Olivia Colman, Benedict Cumberbatch sparkle in dark comedy – Yakima Herald-Republic

    The Roses’ Review: Olivia Colman and Benedict Cumberbatch Shine in Dark Comedy Delight

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Japan’s legacy LCD and chip technology find new home in India – Nikkei Asia

    How Japan’s Breakthrough LCD and Chip Technologies Are Driving Innovation in India

    ITSWC 2025: Thursday sessions guide – Traffic Technology Today

    Your Ultimate Guide to Thursday Sessions at ITSWC 2025

    MC Machinery Technology Summit Showcases Manufacturing Innovations – Modern Machine Shop

    MC Machinery Technology Summit Unveils Cutting-Edge Manufacturing Innovations

    US-ROK Technology Cooperation Faces Rising Tensions – The National Interest

    Rising Tensions Put US-South Korea Technology Partnership to the Test

    The Role of AI and Technology in Shaping the Future of Interactive Entertainment – Technology Org

    How AI and Technology Are Transforming the Future of Interactive Entertainment

    Ten upcoming sports stadiums where technology takes to the field – Dezeen

    10 Futuristic Sports Stadiums Revolutionizing the Game with Cutting-Edge Technology

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

July 5, 2023
in Health
Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program
Share on FacebookShare on Twitter

Berlin, May 16, 2023 – Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian’s first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022.

Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body’s ability to respond to bleeding intact.

Fast Track Designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfill unmet medical needs. The purpose of the program is to get important new therapeutics to the patient earlier. A drug candidate that receives Fast Track Designation may be eligible for more frequent interactions with the U.S. FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

“The second Fast Track Designation for asundexian emphasizes the medical need to prevent stroke and systemic embolism in people diagnosed with atrial fibrillation,” said Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “This designation provides an opportunity to accelerate the development of asundexian and quickly address current patient needs. Despite significant advances in treatment, potential concerns of bleeding risks remain at the forefront of thrombosis management. Asundexian is currently investigated as a candidate in an entirely new class of antithrombotic treatment options aiming to selectively modulate coagulation, address patients with concerns of bleeding, and focus on indications where current anticoagulation is not used.”

It is estimated that up to 40% of eligible patients are either not treated with direct oral anticoagulants or are undertreated, as patients perceive the risk of experiencing bleeding outweigh their need for thrombosis prevention.1 Inhibition of FXIa by asundexian could provide protection from thrombotic events without a corresponding increase in bleeding risk.

About the OCEANIC Program
The OCEANIC clinical trial program is designed to evaluate the use of oral FXIa inhibitor, asundexian, in patients with atrial fibrillation (AF) at risk of stroke and in patients with acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), aiming to improve the benefit-risk profile when compared to current treatment options. The program started with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, and is one of the largest Phase III programs Bayer has undertaken, expecting to enroll more than 27,000 patients in over 40 countries.

About OCEANIC-AF and OCEANIC-STROKE
OCEANIC-AF is a multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, two-arm Phase III study investigating asundexian compared to apixaban (a non-vitamin K antagonist oral anticoagulant) in patients with atrial fibrillation at risk for stroke to determine the safety and efficacy of asundexian on prevention of stroke and systemic embolism.

OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven Phase III study investigating the efficacy and safety of asundexian for prevention of ischemic stroke compared to placebo on top of standard-of-care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk TIA.

About FXIa inhibitors and Asundexian
Factor XI is a protein in the blood which is converted into its active enzyme form (Factor XIa) as part of the blood coagulation cascade. FXIa inhibition specifically targets the FXIa protein involved in pathological thrombus formation, but leaves the pathway involved in the physiological healing of vessel wall injuries intact. Asundexian, as an oral direct, potent inhibitor of activated coagulation factor XI (FXIa), acts selectively on the coagulation cascade, thereby offering the potential to prevent events like stroke without a corresponding increase in bleeding risk. Asundexian is currently being evaluated as a potential improved treatment option in thrombosis prevention and could represent a new approach in antithrombotic treatment. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.

About Atrial Fibrillation
AF is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty completely, and blood does not flow properly, causing blood clots to form. These blood clots can break loose and travel to the brain, resulting in a stroke.2

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on Twitter: @BayerPharma

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. E, Wolff A, Lip GY, Lane DA. Optimising stroke prevention in patients with atrial fibrillation: application of the GRASP-AF audit tool in a UK general practice cohort. Br J Gen Pract. 2015 Jan;65(630):e16-23. doi: 10.3399/bjgp15X683113. PMID: 25548312; PMCID: PMC4276003.​
2. NHS choices. Atrial fibrillation complications. Available at: https://www.nhs.uk/conditions/atrial-fibrillation/complications/ Accessed: May 2023

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Bayer.com – https://www.bayer.com/media/en-us/bayer-receives-us-fda-fast-track-designation-for-asundexian-atrial-fibrillation-program/

Tags: BayerhealthReceives
Previous Post

Slow start to the year as expected

Next Post

Bayer to start Phase III study with finerenone in adults with chronic kidney disease and type 1 diabetes

Mismatches will not halt Women’s Rugby World Cup momentum, insist organisers – The Guardian

Women’s Rugby World Cup Momentum Unstoppable Despite Challenges, Organisers Insist

August 29, 2025
Europe Is Spending Big on Defense. Will That Help Its Ailing Economy? – The New York Times

Europe Is Spending Big on Defense. Will That Help Its Ailing Economy? – The New York Times

August 29, 2025
‘Netflix House’ entertainment complexes are coming. Here’s when they open – Los Angeles Times

Exciting News: Netflix’s House Entertainment Complexes Are Opening Soon!

August 29, 2025
CDC director’s firing prompts health concerns : The News4 Rundown – NBC4 Washington

Firing of CDC Director Ignites Nationwide Health Alarm

August 29, 2025
What’s Behind the Political Instability in Thailand – The New York Times

Unraveling the Root Causes of Political Instability in Thailand

August 29, 2025
Drayton Harbor’s bacteria problem – Washington State Department of Ecology (.gov)

Battling the Bacteria Crisis in Drayton Harbor: Essential Facts You Can’t Miss

August 29, 2025
Entomologists, Fellow Scientists Report Negative Impacts of Government Actions – Entomology Today

Entomologists and Scientists Reveal Alarming Consequences of Recent Government Actions

August 28, 2025
Scientists Reveal What’s Inside Mars: It’s Chunky, With a History of Violence – ScienceAlert

Scientists Reveal Mars’ Chunky Interior and Turbulent History

August 28, 2025
These simple life changes can prevent diabetes and dementia – Earth.com

Easy Lifestyle Changes to Lower Your Risk of Diabetes and Dementia

August 28, 2025
Japan’s legacy LCD and chip technology find new home in India – Nikkei Asia

How Japan’s Breakthrough LCD and Chip Technologies Are Driving Innovation in India

August 28, 2025

Categories

Archives

August 2025
MTWTFSS
 123
45678910
11121314151617
18192021222324
25262728293031
« Jul    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (795)
  • Economy (815)
  • Entertainment (21,694)
  • General (16,733)
  • Health (9,856)
  • Lifestyle (828)
  • News (22,149)
  • People (815)
  • Politics (822)
  • Science (16,024)
  • Sports (21,313)
  • Technology (15,795)
  • World (797)

Recent News

Mismatches will not halt Women’s Rugby World Cup momentum, insist organisers – The Guardian

Women’s Rugby World Cup Momentum Unstoppable Despite Challenges, Organisers Insist

August 29, 2025
Europe Is Spending Big on Defense. Will That Help Its Ailing Economy? – The New York Times

Europe Is Spending Big on Defense. Will That Help Its Ailing Economy? – The New York Times

August 29, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version