Drug updated on 5/17/2024
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).
Latest News
Summary
- Edaravone (Radicava) is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). It has been shown to slightly slow down the progression in ALSFRS-R score at month 6 compared to placebo and improve survival rates at 18, 24, and 30 months without affecting functional outcomes.
- Four systematic reviews/meta-analyses provided information on edaravone's effectiveness in real-world settings as well as its long-term efficacy.
- The use of Radicava did not result in a significant increase in adverse effects compared to placebo or control groups. This was confirmed by all studies reviewed, including a meta-analysis that found no substantial difference in the frequency of adverse events or serious adverse events between edaravone and placebo groups.
- Compared to other drugs for ALS treatment, preliminary inference suggests that Radicava may offer benefits such as slowing disease progression and improving survival rates without increasing the risk of severe side effects.
- Detailed subgroup analyses such as age, gender, or specific ALS phenotypes were not prominently discussed across the studies, but there was an emphasis on the need for further high-quality prospective clinical trials. These trials might provide more detailed subgroup considerations, especially how disease stage could influence treatment outcomes.
- While Radicava shows potential benefits in improving survival rates and slowing disease progression among ALS patients without leading to a significant increase in adverse events when compared with placebos, it is important that further research be conducted to establish the drug's long-term efficacy and understand its impact on various subgroups to confirm these preliminary findings.
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 |