* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Tuesday, September 9, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Monumental Sports & Entertainment Sets Corporate Direction at Nasdaq – PR Newswire

    Monumental Sports & Entertainment Reveals Bold New Corporate Vision at Nasdaq

    The Secret to What Made ‘CarJack’ Work on As the World Turns – yahoo.com

    The Surprising Secret Behind ‘CarJack’s’ Success on As the World Turns

    Victor Garber on his viral “And Just Like That” toilet scene: ‘I was delighted to be doing something ridiculous’ (exclusive) – yahoo.com

    Victor Garber on his viral “And Just Like That” toilet scene: ‘I was delighted to be doing something ridiculous’ (exclusive) – yahoo.com

    Pendulum Announce Homecoming 2026 Australian Tour – yahoo.com

    Pendulum Announces Thrilling Homecoming Tour Across Australia in 2026

    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

  • 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
    Tri-Counties Bank marks 50 years of growth with focus on technology and personal service – thebusinessjournal.com

    Tri-Counties Bank Celebrates 50 Years of Growth Driven by Technology and Personal Service

    AI will reshape internet, create jobs in West Virginia says High Technology Foundation’s Estep – WV News

    How AI Is Set to Transform the Internet and Boost Job Growth in West Virginia

    Industry partner provides Ferris State Plastics Engineering Technology students with state-of-the-art equipment to gain in-demand skills – Ferris State University

    Industry Partner Equips Ferris State Plastics Engineering Students with Cutting-Edge Technology to Boost In-Demand Skills

    Health Technology Ecosystem – Centers for Medicare & Medicaid Services | CMS (.gov)

    Discover the Future of Health Technology: Innovations Revolutionizing Patient Care

    Coherent Joins LLNL’s STARFIRE Diode Technology Working Group to Advance Inertial Fusion Energy – GlobeNewswire

    Coherent Partners with LLNL’s STARFIRE Team to Drive Breakthroughs in Inertial Fusion Energy

    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Monumental Sports & Entertainment Sets Corporate Direction at Nasdaq – PR Newswire

    Monumental Sports & Entertainment Reveals Bold New Corporate Vision at Nasdaq

    The Secret to What Made ‘CarJack’ Work on As the World Turns – yahoo.com

    The Surprising Secret Behind ‘CarJack’s’ Success on As the World Turns

    Victor Garber on his viral “And Just Like That” toilet scene: ‘I was delighted to be doing something ridiculous’ (exclusive) – yahoo.com

    Victor Garber on his viral “And Just Like That” toilet scene: ‘I was delighted to be doing something ridiculous’ (exclusive) – yahoo.com

    Pendulum Announce Homecoming 2026 Australian Tour – yahoo.com

    Pendulum Announces Thrilling Homecoming Tour Across Australia in 2026

    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

  • 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
    Tri-Counties Bank marks 50 years of growth with focus on technology and personal service – thebusinessjournal.com

    Tri-Counties Bank Celebrates 50 Years of Growth Driven by Technology and Personal Service

    AI will reshape internet, create jobs in West Virginia says High Technology Foundation’s Estep – WV News

    How AI Is Set to Transform the Internet and Boost Job Growth in West Virginia

    Industry partner provides Ferris State Plastics Engineering Technology students with state-of-the-art equipment to gain in-demand skills – Ferris State University

    Industry Partner Equips Ferris State Plastics Engineering Students with Cutting-Edge Technology to Boost In-Demand Skills

    Health Technology Ecosystem – Centers for Medicare & Medicaid Services | CMS (.gov)

    Discover the Future of Health Technology: Innovations Revolutionizing Patient Care

    Coherent Joins LLNL’s STARFIRE Diode Technology Working Group to Advance Inertial Fusion Energy – GlobeNewswire

    Coherent Partners with LLNL’s STARFIRE Team to Drive Breakthroughs in Inertial Fusion Energy

    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    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

Amylyx Ditches Controversial ALS Drug

April 4, 2024
in Health
Amylyx Ditches Controversial ALS Drug
Share on FacebookShare on Twitter

Amylyx Pharmaceuticals has announced plans to take sodium phenylbutyrate–taurursodiol (Relyvrio and Albrioza), its drugs for amyotrophic lateral sclerosis (ALS), off the market in the United States and Canada. 

The action stems from disappointing topline results from the phase 3 PHOENIX trial released March 8. 

As reported previously by Medscape Medical News, sodium phenylbutyrate–taurursodiol offered no significant improvements after 48 weeks compared with placebo, failing to meet the randomized controlled trial”s primary or secondary endpoints.

The data prompted the watchdog group Public Citizen to call for the immediate removal of sodium phenylbutyrate–taurursodiol from the market. 

Based on the topline data, Amylyx said the drug will no longer be available for new patients as of April 4. Patients currently on the drug in the United States and Canada who, in consultation with their physician, want to remain on treatment can be transitioned to a free drug program, the company said in a statement.

“While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS and other neurodegenerative diseases,” Joshua Cohen and Justin Klee, co-CEOs of Amylyx, said in the statement. 

“The decision to remove Relyvrio/Albrioza from the market and provide therapy free of charge for those who wish to continue was informed by the PHOENIX trial results, engagement with regulatory authorities, and discussions with the ALS community,” Cohen and Klee said. 

Checkered History 

The US Food and Drug Administration (FDA) approved the drug in September 2022. The decision followed an unusual review process that began in March 2022 with an initial recommendation from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee not to approve the drug due to insufficient evidence of efficacy.

The expert panel’s recommendation against approval was criticized by patients and other advocates for failing to consider the unmet medical need in ALS and the seriousness and lethality of the disease. 

After updated data provided by the manufacturer and an aggressive campaign by patients with ALS and associated advocates, the FDA delayed its final ruling on the drug’s approval and reconvened the panel for a rare second review.

This time, the panel was not asked whether the data provided conclusive evidence of efficacy, rather whether the data were sufficient for approval. It also received broader latitude to consider the unmet medical need and lethality of ALS. 

After this meeting, the committee did an about-face and voted seven to two in favor of the drug’s approval.

Amylyx continues to study the drug (also known as AMX0035) in Wolfram syndrome and progressive supranuclear palsy (PSP), as well as another agent, AMX0114, an antisense oligonucleotide targeting calpain 2, in ALS.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/amylyx-ditches-controversial-als-drug-relyvrio-2024a10006g2

Tags: Amylyxditcheshealth
Previous Post

Over $500 million in crypto stolen during Q1 through exploits: CertiK

Next Post

One in Every 200 US Adults Has Type 1 Diabetes

Pope Leo XIV: Caring for Creation is our vocation – Vatican News

Pope Leo XIV: Caring for Creation is our vocation – Vatican News

September 9, 2025
Ocean Sciences Meeting will convene in Glasgow Scotland, February 2026 – EurekAlert!

Get Ready for the Ocean Sciences Meeting Making Waves in Glasgow This February 2026!

September 9, 2025
The Christian Science Monitor | Grand Juries Usually Approve Indictments. In LA and DC, They’re Pushing Back. – Loyola Marymount University

Grand Juries Typically Approve Indictments-But in LA and DC, They’re Starting to Push Back

September 9, 2025
Lifestyle Communities Finalizes Ocean Grove Land Sale – TipRanks

Lifestyle Communities Finalizes Ocean Grove Land Sale – TipRanks

September 9, 2025
Tri-Counties Bank marks 50 years of growth with focus on technology and personal service – thebusinessjournal.com

Tri-Counties Bank Celebrates 50 Years of Growth Driven by Technology and Personal Service

September 9, 2025
Bears inform fans of plans to leave Soldier Field, finalize stadium in Arlington Heights for Super Bowl bid – CBS Sports

Bears inform fans of plans to leave Soldier Field, finalize stadium in Arlington Heights for Super Bowl bid – CBS Sports

September 9, 2025
Ten standout moments from World Cup pool stage – BBC

Ten Unforgettable Moments That Defined the World Cup Pool Stage

September 8, 2025
The supply and demand seesaw is sending mixed signals about the economy – MSN

The Supply and Demand Tug-of-War Is Sending Confusing Signals About the Economy

September 8, 2025
Why this San Antonio shopping center could be an entertainment hub – MySA

How This San Antonio Shopping Center Is Set to Become the Ultimate Entertainment Destination

September 8, 2025
Wearable health trackers reveal how accurate your smartwatch really is – News-Medical

Wearable health trackers reveal how accurate your smartwatch really is – News-Medical

September 8, 2025

Categories

Archives

September 2025
MTWTFSS
1234567
891011121314
15161718192021
22232425262728
2930 
« Aug    
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 (814)
  • Economy (831)
  • Entertainment (21,708)
  • General (16,932)
  • Health (9,873)
  • Lifestyle (845)
  • News (22,149)
  • People (834)
  • Politics (838)
  • Science (16,041)
  • Sports (21,331)
  • Technology (15,812)
  • World (813)

Recent News

Pope Leo XIV: Caring for Creation is our vocation – Vatican News

Pope Leo XIV: Caring for Creation is our vocation – Vatican News

September 9, 2025
Ocean Sciences Meeting will convene in Glasgow Scotland, February 2026 – EurekAlert!

Get Ready for the Ocean Sciences Meeting Making Waves in Glasgow This February 2026!

September 9, 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