Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 30 mg/100 mL); Suspension (oral; 105 mg/5 mL) |
Drug Class | Unknown mechanism of action |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
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Summary
- Radicava (edaravone) is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- ALSFRS-R Scores: Edaravone demonstrated a slightly slower reduction in ALSFRS-R score at 6 months compared to placebo (MD 1.01, 95% CI -0.87 to 3.09, p = 0.293), but observational studies showed no benefit (MD 1.85, 95% CI -2.05 to 5.75, p = 0.352). Significant differences were noted in other studies at 24 weeks (MD 1.63, 95% CI 0.26-3.00, p = 0.02) and between groups (MD 1.33, 95% CI 0.33-2.34, p = 0.009).
- Survival Rates: Edaravone improved survival rates at 18, 24, and 30 months with risk ratios of 1.03 (95% CI 1.02 to 1.24, p = 0.02), 1.22 (95% CI 1.06 to 1.41, p = 0.007), and 1.17 (95% CI 1.01 to 1.34, p = 0.03), respectively.
- Other Functional Outcomes: Increased grip strength (MD 0.26, 95% CI 0.03-0.49, p = 0.03) and modified Norris Scale scores (MD 2.81, 95% CI 1.18-4.43, p = 0.0007) were reported for edaravone, with no significant differences in FVC%, pinch strength, or ALSAQ-40 scores. Another study reported no effect on functional outcomes.
- There were no significant differences in the incidence of adverse events, serious adverse events, or deaths between the edaravone and placebo groups across multiple studies (e.g., RR for AEs 0.09, 95% CI 0.93-1.05, p = 0.65; RR for SAEs 0.72, 95% CI 0.52-1.00, p = 0.05; OR for AEs 1.22, 95% CI 0.68-2.19, p = 0.50; OR for SAEs 0.71, 95% CI 0.43-1.19, p = 0.20).
- No significant safety concerns or adverse effects were highlighted in the studies.
- 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 |
---|---|---|
Edaravone for patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis. | 2024 | Acta Neurologica Belgica |
Safety and efficacy of edaravone in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis. | 2023 | Neurological Sciences |
Safety and efficacy of edaravone in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis. | 2022 | Clinical Drug Investigation |
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 |