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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:  
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

  • Neudexta
  • Radicava/Edaravone
  • Riluzole/Tiglutik
  • Tofersen/Qalsody

  • Bayley, Australia

    Bayley, Australia

  • Marco Antonio Alvarez Mercado, Mexico

    Marco Antonio Alvarez Mercado, Mexico

  • Paul Launer, USA

    Paul Launer, USA

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • Carlos Alberto Báez Murillo, ACELA, Colombia

    Carlos Alberto Báez Murillo, ACELA, Colombia

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

    Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

  • Angela Jansen, Deutsche Gesellschaft für Muskelkranke e.V.-DGM, Diagnosed 1995, Germany

    Angela Jansen, Deutsche Gesellschaft für Muskelkranke e.V.-DGM, Diagnosed 1995, Germany

  • Andrietta

    Andrietta

  • IMG_1211

    IMG_1211

  • Mary Thomas, Diagnosed 2013 , MND Australia

    Mary Thomas, Diagnosed 2013 , MND Australia

  • Richard Clark, MND New Zealand,  Diagnosed 2011

    Richard Clark, MND New Zealand, Diagnosed 2011

  • Ali Var, Turkey

    Ali Var, Turkey

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
    Picture1

  • Brian Lovell, Diagnosed 2011 . MND Australia

    Brian Lovell, Diagnosed 2011 . MND Australia

  • Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

    Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • Cath Muir

    Cath Muir
    Cath

  • Juvenal Bayona Romero

    Juvenal Bayona Romero

  • Oliver Juenke, Germany

    Oliver Juenke, Germany

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

  • Duncan Bayly , MND Australia

    Duncan Bayly , MND Australia

  • March of Faces Photo Submission_OLGA_ELA ARGENTINA

    March of Faces Photo Submission_OLGA_ELA ARGENTINA

  • Kirsty Gerlach, MND New Zealand, Diagnosed 2017

    Kirsty Gerlach, MND New Zealand, Diagnosed 2017

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

  • Alan Liz Ogg 29042016 000799 lo res

    Alan Liz Ogg 29042016 000799 lo res

  • Hollister

    Hollister
    hollister

  • Joanne Pratt, Diagnosed 2011 , MND Australia

    Joanne Pratt, Diagnosed 2011 , MND Australia

  • Valdomiro Xavier Honório, Brazil

    Valdomiro Xavier Honório, Brazil

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

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

  • Jean Waters, Diagnosed 2004, MND Association of England, Wales and N Ireland

    Jean Waters, Diagnosed 2004, MND Association of England, Wales and N Ireland

  • Daniel Hare

    Daniel Hare

  • Kris Van Reusel, Belgium

    Kris Van Reusel, Belgium

  • Jon Newsome, USA

    Jon Newsome, USA

  • March of Faces Photo Submission_ALEX_ELA ARGENTINA

    March of Faces Photo Submission_ALEX_ELA ARGENTINA

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Kirsten Harley,  Diagnosed 2013,  Australia

    Kirsten Harley, Diagnosed 2013, Australia

  • Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

    Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

  • Jean

    Jean
    jean

  • Elisabeth Zahnd, Switzerland

    Elisabeth Zahnd, Switzerland

  • Claire Garry, USA

    Claire Garry, USA
    20200117_214643

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Steven Spencer, Diagnosed 2014 , MND New Zealand

    Steven Spencer, Diagnosed 2014 , MND New Zealand

  • Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

    Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

  • Roy

    Roy
    roy

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

    Angie Bordaen, Diagnosed 2014, ALS Liga België, Belgium

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

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

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

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

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