edaravone (Radicava)

^[1]^[2]^[3]

Indications

treatment of amyotrophic lateral sclerosis (ALS)
- may benefit mildly symptomatic patients (probably not)^[3]

intravenous infusion
- initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period
- subsequently dosing on 10 of 14 days, followed by a 14 day drug-free period

contains sodium bisulfite
orphan drug designation
- potentially high price tag, despite generic versions available in China & India

↑ Fiore K FDA Okays Antioxidant Drug for ALS - Drug may work best in patients with preserved function. MedPage Today. May 5, 2017 https://www.medpagetoday.com/Neurology/GeneralNeurology/65087
FDA News Release. May 5, 2017 FDA approves drug to treat ALS https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm
Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871
U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
↑ Tanaka M, et al. A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.189). American Academy of Neurology Annual Meeting. Vancouver, BC. 2016 Apr 18.
↑ ^3.0 ^3.1 ^3.2 George J Does Edaravone Slow ALS Progression? Even in subgroup with expected efficacy, prospective study finds no significant effect. MedPage Today January 10, 2022 https://www.medpagetoday.com/neurology/generalneurology/96576
Witzel S, Maier A, Steinbach R et al Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. Published online January 10, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35006266 https://jamanetwork.com/journals/jamaneurology/fullarticle/2787473