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Radicava (edaravone) for amyotrophic lateral sclerosis: US experience at 1 year after launch.

Abstract

Background:

Radicava® (edaravone), approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2017, may be administered intravenously at clinic sites, infusion centers or at home.

Objective:

To gain insights into the utilization of Radicava® at 1 year post-launch.

Methods:

Radicava® usage data were collected, and a survey was conducted among 75 physicians. Adverse events (AEs) were identified from a post-marketing safety database from 8 August 2017 through 3 August 2018 (cutoff date).

Results:

As of 6 August 2018, 3007 ALS patients were treated with Radicava®. Survey results indicated that 43% of patients received infusions at home, 32% in a clinician's office, and 26% at a referred site. Infusions were administered mainly via implanted port. The most commonly reported AEs were drug ineffective, death (not specified), therapeutic response unexpected, asthenia, fatigue, gait disturbance, disease progression, muscular weakness, fall, and dyspnea.

Conclusions:

The first year of Radicava® availability to ALS patients in the US provided many key learnings that will help shape strategies for improved patient care.

Authors+Show Affiliations

University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.Temple University Lewis Katz School of Medicine , Philadelphia , PA , USA.University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.Mitsubishi Tanabe Pharma America, Inc , Jersey City , NJ , USA , and.Mitsubishi Tanabe Pharma America, Inc , Jersey City , NJ , USA , and.Mitsubishi Tanabe Pharma Development America, Inc , Jersey City , NJ , USA.Mitsubishi Tanabe Pharma America, Inc , Jersey City , NJ , USA , and.Mitsubishi Tanabe Pharma America, Inc , Jersey City , NJ , USA , and.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31364409

Citation

Jackson, Carlayne, et al. "Radicava (edaravone) for Amyotrophic Lateral Sclerosis: US Experience at 1 Year After Launch." Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration, vol. 20, no. 7-8, 2019, pp. 605-610.
Jackson C, Heiman-Patterson T, Kittrell P, et al. Radicava (edaravone) for amyotrophic lateral sclerosis: US experience at 1 year after launch. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20(7-8):605-610.
Jackson, C., Heiman-Patterson, T., Kittrell, P., Baranovsky, T., McAnanama, G., Bower, L., ... Martin, M. (2019). Radicava (edaravone) for amyotrophic lateral sclerosis: US experience at 1 year after launch. Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration, 20(7-8), pp. 605-610. doi:10.1080/21678421.2019.1645858.
Jackson C, et al. Radicava (edaravone) for Amyotrophic Lateral Sclerosis: US Experience at 1 Year After Launch. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20(7-8):605-610. PubMed PMID: 31364409.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Radicava (edaravone) for amyotrophic lateral sclerosis: US experience at 1 year after launch. AU - Jackson,Carlayne, AU - Heiman-Patterson,Terry, AU - Kittrell,Pamela, AU - Baranovsky,Tatyana, AU - McAnanama,Glenn, AU - Bower,Laura, AU - Agnese,Wendy, AU - Martin,Mike, Y1 - 2019/07/31/ PY - 2019/8/1/pubmed PY - 2019/8/1/medline PY - 2019/8/1/entrez KW - SP - 605 EP - 610 JF - Amyotrophic lateral sclerosis & frontotemporal degeneration JO - Amyotroph Lateral Scler Frontotemporal Degener VL - 20 IS - 7-8 N2 - Background: Radicava® (edaravone), approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2017, may be administered intravenously at clinic sites, infusion centers or at home. Objective: To gain insights into the utilization of Radicava® at 1 year post-launch. Methods: Radicava® usage data were collected, and a survey was conducted among 75 physicians. Adverse events (AEs) were identified from a post-marketing safety database from 8 August 2017 through 3 August 2018 (cutoff date). Results: As of 6 August 2018, 3007 ALS patients were treated with Radicava®. Survey results indicated that 43% of patients received infusions at home, 32% in a clinician's office, and 26% at a referred site. Infusions were administered mainly via implanted port. The most commonly reported AEs were drug ineffective, death (not specified), therapeutic response unexpected, asthenia, fatigue, gait disturbance, disease progression, muscular weakness, fall, and dyspnea. Conclusions: The first year of Radicava® availability to ALS patients in the US provided many key learnings that will help shape strategies for improved patient care. SN - 2167-9223 UR - https://www.unboundmedicine.com/medline/citation/31364409/Radicava__edaravone__for_amyotrophic_lateral_sclerosis:_US_experience_at_1_year_after_launch_ L2 - http://www.tandfonline.com/doi/full/10.1080/21678421.2019.1645858 DB - PRIME DP - Unbound Medicine ER -