Mitsubishi Tanabe Pharma America to Present New RADICAVA ORS® Data at 2024 AMCP Nexus Meeting

JERSEY CITY, N.J., Oct. 10, 2024 -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) recently revealed findings from a real-world study analyzing healthcare resource utilization among amyotrophic lateral sclerosis (ALS) patients treated with RADICAVA ORS® (edaravone). This data, sourced from a U.S. administrative claims database, is set to be presented at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting in Las Vegas, Nev., from October 14-17.

Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA, expressed enthusiasm about presenting the new data at the AMCP Nexus conference. "By examining how RADICAVA ORS is used among different patient demographics and insurance types, we hope to foster more informed healthcare strategies," he said.

The presentation will provide updated results from a real-world observational study, detailing the demographics, clinical characteristics, and healthcare resource utilization (HCRU) of ALS patients treated with RADICAVA ORS. Data from Optum's de-identified Clinformatics® Data Mart (CDM) offers insights into treatment patterns of two patient groups: those who transitioned from intravenous edaravone to oral edaravone, and those who had not previously received edaravone before starting on the oral formulation.

The session, titled "Healthcare Resource Utilization of Oral Edaravone-Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a U.S.-Based Administrative Claims Database," will be presented by Malgorzata Ciepielewska, M.S., from MTPA. The poster session is scheduled for October 15 from 5 p.m. to 7:00 p.m. PDT and October 16 from 1:00 p.m. to 2:30 p.m. PDT.

RADICAVA® (edaravone) and its oral formulation, RADICAVA ORS®, were both approved by the U.S. Food and Drug Administration (FDA) for the treatment of ALS, in May 2017 and May 2022, respectively. The FDA granted RADICAVA ORS Orphan Drug Exclusivity in 2024, acknowledging the significant contribution of the oral formulation to patient care. RADICAVA is delivered in 28-day cycles via intravenous infusion, whereas RADICAVA ORS is administered orally, with a specific regimen involving treatment and drug-free periods.

The discovery and development of edaravone for ALS was undertaken by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by MTPA. Research on ALS by MTPC began in 2001 and continued over a 13-year period using a clinical platform approach. RADICAVA was approved as RADICUT® in Japan and South Korea in 2015, with subsequent marketing authorizations in Canada, Switzerland, Indonesia, Thailand, Malaysia, and Brazil. RADICAVA Oral Suspension also received approval in Canada and Switzerland, while RADICUT® Oral Suspension 2.1% was approved in Japan. In the U.S., RADICAVA and RADICAVA ORS have been used to treat over 16,000 ALS patients, resulting in more than 2 million days of therapy and prescriptions by over 2,400 healthcare providers.

Patients who have a history of hypersensitivity to edaravone or its inactive ingredients should avoid using RADICAVA and RADICAVA ORS due to the risk of severe allergic reactions, including anaphylaxis. Common adverse reactions include contusion, gait disturbance, headache, and fatigue. Additionally, due to the presence of sodium bisulfite, patients with sulfite sensitivity, particularly those with asthma, may experience allergic-type reactions.

RADICAVA and RADICAVA ORS are indicated for ALS treatment.

Mitsubishi Tanabe Pharma America, Inc. (MTPA), is based in Jersey City, N.J., and is a subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). Established to develop and commercialize pharmaceutical products in North America, MTPA operates under the mission of creating hope for those facing illness, with a focus on central nervous system, immuno-inflammation, diabetes, kidney diseases, and cancer. Their approach emphasizes precision medicine to deliver high-treatment satisfaction and solutions addressing specific patient concerns.