Mitsubishi Tanabe Pharma to Showcase RADICAVA ORS® Data at 2024 ALS Nexus

JERSEY CITY, N.J., July 9, 2024 -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) has unveiled four abstracts on amyotrophic lateral sclerosis (ALS) at the inaugural ALS Nexus Conference in Dallas, Texas, from July 14-17, 2024. The presentations will highlight findings from several real-world ALS studies, including treatment analyses with RADICAVA® (edaravone).

A significant component of the conference will be MTPA's program, which will focus on the clinical history, efficacy, safety, and real-world experience of RADICAVA ORS® (edaravone). Dr. Gary Pattee will present clinical evidence supporting the product, joined by patient advocate Gwen Petersen, who will share her personal journey and the role RADICAVA ORS has played in her life. 

Key sessions include:
- "From Clinical Trials to Real-World Experience": July 16, 12:55 p.m. – 2:00 p.m. CT
- "Treatment Patterns and Survival Benefit of Edaravone–Treated People with Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium" (Stephen Apple, M.D.): July 16, 4:00 p.m. – 6:00 p.m. CT
- "Preliminary Analysis of Treatment Combinations in Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database" (Malgorzata Ciepielewska, MS): July 16, 4:00 p.m. – 6:00 p.m. CT
- "Preliminary Analysis of Treatment Patterns in Patients with Amyotrophic Lateral Sclerosis Using Electronic Health Records" (Stephen Apple, M.D.): July 16, 4:00 p.m. – 6:00 p.m. CT
- "Healthcare Resource Utilization of Oral Edaravone–Treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database" (Malgorzata Ciepielewska, MS): July 16, 4:00 p.m. – 6:00 p.m. CT

MTPA aims to provide valuable insights from their clinical and real-world studies to help healthcare providers create personalized treatment plans for ALS. Dr. Gustavo A. Suarez Zambrano, Vice President of Medical Affairs at MTPA, emphasized the importance of collaboration in navigating the challenges of ALS treatment.

About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)

RADICAVA® (edaravone) received approval from the U.S. Food and Drug Administration (FDA) on May 5, 2017, followed by the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for treating amyotrophic lateral sclerosis (ALS). In 2024, RADICAVA ORS was granted Orphan Drug Exclusivity by the FDA due to its significant contribution to patient care.

RADICAVA is administered via intravenous (IV) infusion in 28-day cycles. The first 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 span, followed by two weeks off. RADICAVA ORS is consumed orally, with the first cycle involving daily doses for 14 consecutive days followed by a 14-day break. Subsequent cycles require doses for 10 days within a 14-day period followed by a 14-day break. Patients must take RADICAVA ORS in the morning after overnight fasting and avoid eating or drinking (except water) for an hour afterwards.

Edaravone, developed by Mitsubishi Tanabe Pharma Corporation (MTPC) for ALS, was first approved as RADICUT® in Japan and South Korea in 2015. Over the years, it received marketing authorizations in several countries, including Canada, Switzerland, Indonesia, Thailand, Malaysia, and Brazil. To date, RADICAVA and RADICAVA ORS have been used to treat over 16,000 ALS patients in the U.S., with more than 1.9 million days of therapy and over 2,400 healthcare providers prescribing it.

Safety Information

Patients with a history of hypersensitivity to edaravone or any inactive ingredients should avoid RADICAVA and RADICAVA ORS. Hypersensitivity reactions and anaphylaxis have been reported. The medications contain sodium bisulfite, which can trigger allergic reactions in susceptible individuals, especially asthmatics. Common adverse reactions include contusion, gait disturbance, and headache, with fatigue observed in some patients taking RADICAVA ORS. 

RADICAVA and RADICAVA ORS are indicated for treating ALS. For complete prescribing information, patients should consult healthcare professionals.

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