Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 30 mg/100 mL); Suspension (oral; 105 mg/5 mL) |
Drug Class | Antioxidants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Intravenous edaravone showed a statistically significant improvement in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score compared to placebo, with a mean difference of 1.63 (95% confidence interval (CI): 0.26-3.00, p = 0.02) at 24 weeks, indicating potential efficacy in amyotrophic lateral sclerosis patients.
- No significant differences were observed in the frequency of adverse events (odds ratio (OR): 1.22, 95% CI: 0.68-2.19, p = 0.50) or serious adverse events (OR: 0.71, 95% CI: 0.43-1.19, p = 0.20) between the edaravone and placebo groups, suggesting a favorable safety profile for edaravone.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Radicava (edaravone) Prescribing Information. | 2022 | Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of edaravone in treatment of amyotrophic lateral sclerosis-a systematic review and meta-analysis | 2019 | Neurological Sciences |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Canadian best practice recommendations for the management of amyotrophic lateral sclerosis | 2020 | Canadian Medical Association Journal |