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Radicava/Edaravone

Edaravone is a drug sold under the names, Radicava or Radicut. Japan, South Korea, Canada, Switzerland, China, Indonesia, Thailand, Malaysia, Brazil and the United States have approved its use to treat people with Amyotrophic Lateral Sclerosis (ALS) or Motor Neuron Disease (MND).

Background

Intravenous (IV) edaravone (Radicut) has been used in Japan since 2001 for the acute treatment of neurological symptoms related to ischemic stroke. Based on its proposed mechanism of action, a Japanese clinician suggested edaravone may be effective in treating ALS/MND. This led Mitsubishi Tanabe Pharma America, the owners of Radicut, to examine this possibility in clinical trials.

Approved in:    Commercial Name:  
Australia Radicava® 
Brazil  Radicava® 
Canada  Radicava® injection 30 mg/100 mL 
Radicava Oral Suspension (ORS) 
Japan  Radicut® bag 30 mg/100 mL   

Radicut® ampule 30 mg/20 mL 

RADICUT® Oral Suspension 2.1% 
Indonesia   Radicava® IV concentrate solution for infusion 30 mg/20 mL 
Malaysia  Radicava® IV concentrate solution for infusion 30 mg/20 mL 
South Korea  Radicut® ampule 30 mg/20 mL 
Switzerland   Radicava® 30 mg/100 mL 
Radicava® oral suspension 
Thailand   Radicava® 
USA  Radicava® 30 mg/100 mL 
Radicava Oral Suspension (ORS) 

Proposed Mechanism of Action

Several studies have shown that edaravone may act as a free-radical scavenger (or antioxidant) and may protect cells from damage inflicted by oxidative stress, which is hypothesized to be one of the mechanisms causing neuronal toxicity in ALS/MND. Currently it remains unclear how edaravone may have an effect in ALS/MND and studies are ongoing. All other clinical trials using antioxidant compounds have been ineffective for treating ALS/MND to date.

Edaravone IV in Clinical Trials

Multiple clinical trials of edaravone (Radicut) in ALS/MND were conducted in Japan for more than a decade. An initial double-blind, placebo-controlled study (MC-186) demonstrated a trend towards benefit for those treated with edaravone, but this was not statistically significant. Follow up (post-hoc) analysis revealed that a subgroup of participants earlier in the disease appeared to benefit compared to those further progressed. A second double-blind, placebo-controlled clinical trial was conducted, enrolling only individuals with the earlier disease criteria observed to benefit in the previous study and a statistically significant benefit was observed, with a difference of 2.49 ALSFRS-r points between the active treatment and placebo groups over 24 weeks. These results led to approval of edaravone in several countries, notably by the United States FDA in 2017 as Radicava.

Since approval of IV Radicava, MT Pharma has created an oral suspension formulation, which was approved by the FDA as Radicava ORS and Health Canada as Radicava Oral Suspension in 2022. Further clinical trials demonstrated that the oral edaravone acts in an equivalent manner in the body, is safe and is well tolerated.

Another oral formulation of edaravone, TW001, was created by the company Treeway in The Netherlands. TW001, also called FAB122, was tested in a double-blind, placebo-controlled Phase 3 clinical trial across Europe, called the ADORE study, that did not demonstrate benefit versus placebo. It is unknown how comparable this form of edaravone is to the MT Pharma drug and more details are expected later in 2024. More information about the oral formulation of Radicava can be found here.

Dose and Administration

Administration of edaravone occurs as a 28-day cycle. Edaravone is administered via IV infusion of 60 mg over 60 minutes once daily for 14 days followed by 14-days of a treatment-free period, after which the cycle repeats with a change to edaravone only on 10 out of 14 days during the treatment period. RADICAVA ORS uses the same dosing regimen as RADICAVA IV and is administered orally via mouth or feeding tube with a 5mL syringe.

Reported Side Effects

Edaravone is generally safe and well tolerated at the recommended dose. Commonly reported adverse effects of edaravone IV administration include issues walking, bruising, headaches, fatigue, and constipation. Serious adverse events reported from these studies include respiratory disorders, dysphagia, pneumonia aspiration, and musculoskeletal disorders.

Edaravone should be administered and monitored under the care of a physician.

Current Status

Our understanding of edaravone as a treatment for ALS/MND is constantly evolving. There are conflicting results with some studies suggesting a small benefit while other studies show no benefit. As more information arises, the Alliance will attempt to keep this document updated with current learnings.

Disclaimer: Consult with your doctor to determine if edaravone/Radicava is an option for you. Always disclose your medical history, including any drugs, natural supplements, or herbal medicines currently being used. Your doctor will determine the right plan for your needs.

SOURCES

  • http://www.ncbi.nlm.nih.gov/pubmed/?term=Abe+K+et+al.+Amyotroph+Lateral+Scler+Frontotemporal+Degener+2014%3B+15%3A+610-7  
  • https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(17)30115-1/abstract  
  • https://pubmed.ncbi.nlm.nih.gov/32062193/  
  • https://www.als.org/navigating-als/living-with-als/fda-approved-drugs/edaravone#researchers  
  • https://pubmed.ncbi.nlm.nih.gov/36504406/ 
  • https://pubmed.ncbi.nlm.nih.gov/33955162/ 
  •  https://www.radicava.com/patient/understanding-radicava/#an-oral-form 

International Alliance of ALS/MND Associations
September 2024


The original language of communication is English and any translation cannot be guaranteed for accuracy of messaging.

Primary Sidebar

Approved Drugs

  • Nuedexta
  • Radicava/Edaravone
  • Riluzole/Tiglutik
  • Rozebalamin/Methylcobalamin
  • Tofersen/Qalsody

  • H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

    H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Inta Grubb, Diagnosed 2014,  MND Australia

    Inta Grubb, Diagnosed 2014, MND Australia

  • Angie Bordaen, Diagnosed 2014,  ALS Liga België, Belgium

    Angie Bordaen, Diagnosed 2014, ALS Liga België, Belgium

  • Chen Chun-Chin

    Chen Chun-Chin

  • Chih Ching Darren Wong, MND Malaysia

    Chih Ching Darren Wong, MND Malaysia

  • Xian-Zhang Niu, Diagnosed 2006 , Shaanxi ALS Association, China

    Xian-Zhang Niu, Diagnosed 2006 , Shaanxi ALS Association, China

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Hollister

    Hollister
    hollister

  • Horacio Fritzer, Argentina

    Horacio Fritzer, Argentina

  • Steve Lufkin, USA

    Steve Lufkin, USA
    IMG_3993

  • Joy Blakeley, Diagnosed 2017 , MND Australia

    Joy Blakeley, Diagnosed 2017 , MND Australia

  • Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

    Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

  • Michel Perrozzo, ARSLA, Diagnosed 2015, France

    Michel Perrozzo, ARSLA, Diagnosed 2015, France

  • Shera Mukherjee, Diagnosed 2013,  Asha Ek Hope Foundation, India

    Shera Mukherjee, Diagnosed 2013, Asha Ek Hope Foundation, India

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

    Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

  • Tammy Moore and Eddy Lefrancois

    Tammy Moore and Eddy Lefrancois

  • Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

    Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

  • Maurice LeClerc, ALS Canada

    Maurice LeClerc, ALS Canada

  • Art Eggert, USA

    Art Eggert, USA

  • Carlos Alberto Báez Murillo, ACELA, Colombia

    Carlos Alberto Báez Murillo, ACELA, Colombia

  • Andrea Zicchieri, Associazione conSLAncio Onlus, Italy

    Andrea Zicchieri, Associazione conSLAncio Onlus, Italy
    AndreaZicchieri_conSLAncioItaly

  • Lombana, Spain

    Lombana, Spain

  • Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

    Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

  • unnamed

    unnamed

  • Liz Ogg, Diagnosed 2013 , MND Scotland, UK

    Liz Ogg, Diagnosed 2013 , MND Scotland, UK

  • Nicholas (Nic) Bowman, MND Association of South Africa,  Diagnosed 2016,  Australia

    Nicholas (Nic) Bowman, MND Association of South Africa, Diagnosed 2016, Australia

  • Denis Blais, Diagnosed 2015 , ALS Canada

    Denis Blais, Diagnosed 2015 , ALS Canada

  • Greg Heydet, ALS Hope Foundation, USA

    Greg Heydet, ALS Hope Foundation, USA

  • Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

    Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

  • Kris Van Reusel, Belgium

    Kris Van Reusel, Belgium

  • Marcel R. Wernard, Diagnosed 2016,  ALS Patients Connected,  The Netherlands

    Marcel R. Wernard, Diagnosed 2016, ALS Patients Connected, The Netherlands

  • Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

    Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
    Picture1

  • March of Faces Photo Submission_OLGA_ELA ARGENTINA

    March of Faces Photo Submission_OLGA_ELA ARGENTINA

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Susan Keldani, Les Turner ALS Foundation, USA

    Susan Keldani, Les Turner ALS Foundation, USA

  • Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

    Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

  • Cath Muir

    Cath Muir
    Cath

  • Armando González Gómez, ACELA, Colombia

    Armando González Gómez, ACELA, Colombia

  • Richard Clark, MND New Zealand,  Diagnosed 2011

    Richard Clark, MND New Zealand, Diagnosed 2011

  • Conny van der Meijden, Diagnosed 2001,  ALS Netherlands

    Conny van der Meijden, Diagnosed 2001, ALS Netherlands

  • Glen Elison,  ALS Hope Foundation,  Diagnosed 2019,  USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Jean

    Jean
    jean

  • Alejandro Aquino, Diagnosed 2011 , Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 , Asociación ELA Argentina

  • Ian Gale, MND Australia

    Ian Gale, MND Australia

  • Monica Soriano, Diagnosed 2011 ,  Asociación ELA , Argentina

    Monica Soriano, Diagnosed 2011 , Asociación ELA , Argentina

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