Mitsubishi Tanabe Pharma America, Inc. (MTPA) presented new data on RADICAVA ORS® (edaravone) at the 2024 National Association of Specialty Pharmacy (NASP) Annual Meeting and Expo in Nashville, TN, October 6-9. The presentations focused on real-world observational analyses of patients with amyotrophic lateral sclerosis (ALS) treated with RADICAVA ORS®.
The data included insights into patient demographics, treatment duration, progression milestones, and healthcare resource utilization. These findings aim to provide a comprehensive view of the clinical and economic impact of RADICAVA ORS® in treating individuals with ALS.
Real-World Observational Analysis
Updated results from an ongoing real-world observational analysis were presented, focusing on patient demographics, treatment duration, and progression milestones up to the first RADICAVA ORS® dosing. This analysis provides valuable insights into the characteristics of patients initiating treatment with the oral formulation of edaravone.
Healthcare Resource Utilization
An analysis of clinical characteristics and healthcare resource utilization data, drawn from Optum's de-identified Clinformatics® Data Mart (CDM), was also presented. This analysis offers insights into the real-world impact of RADICAVA ORS® on healthcare resource utilization among individuals with ALS.
RADICAVA ORS® (edaravone) Background
RADICAVA® (edaravone) was initially approved by the U.S. Food and Drug Administration (FDA) on May 5, 2017, for the treatment of amyotrophic lateral sclerosis (ALS). The oral formulation, RADICAVA ORS® (edaravone), was subsequently approved on May 12, 2022. In 2024, RADICAVA ORS® received Orphan Drug Exclusivity from the FDA, recognizing its significant contribution to patient care through its innovative oral formulation.
RADICAVA is administered intravenously (IV) in 28-day cycles, with each 60 mg dose taking 60 minutes to infuse. The initial cycle involves daily infusions for 14 consecutive days, followed by a two-week drug-free period. Subsequent cycles consist of daily infusions for 10 days within a 14-day period, followed by a two-week drug-free period.
RADICAVA ORS is taken daily for 14 consecutive days, followed by a 14-day drug-free period for the initial treatment cycle. Subsequent treatment cycles involve taking RADICAVA ORS for 10 days within a 14-day period, followed by a 14-day drug-free period. It is recommended to take RADICAVA ORS in the morning after overnight fasting, and patients should avoid eating or drinking (except water) for one hour after administration.
Safety Information
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients. Hypersensitivity reactions, including anaphylaxis, have been reported. Patients should be monitored carefully, and treatment should be discontinued if such reactions occur.
Both formulations contain sodium bisulfite, a sulfite that may cause allergic-type reactions in susceptible individuals. The most common adverse reactions reported in RADICAVA-treated patients include contusion (15%), gait disturbance (13%), and headache (10%). Fatigue was observed in 7.6% of patients receiving RADICAVA ORS in an open-label study. Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
Commitment to ALS
"MTPA is pleased to share these important findings on RADICAVA ORS at the 2024 NASP Annual Meeting," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These results continue to underscore our commitment to advancing medical knowledge and improving patient care, offering a comprehensive view of how our innovations impact both clinical outcomes and healthcare resource utilization."
