MTPA Supports the ALS Community

Mitsubishi Tanabe Pharma America, Inc. (MTPA), based in Jersey City, N.J., is currently navigating a complex period marked by external challenges in the field of amyotrophic lateral sclerosis (ALS) treatment. The company is acutely aware of the substantial need for effective ALS therapies and acknowledges the widespread impact setbacks can have on the entire ALS community.

MTPA is committed to its mission of supporting the ALS community through continued research, treatments, advocacy, and patient resources. The company is focused on advancing its understanding of ALS, particularly through the ongoing evaluation of RADICAVA ORS® (edaravone) and the intravenous (IV) version of RADICAVA® (edaravone). Both forms of RADICAVA are FDA-approved treatments designed to slow the loss of physical function in ALS patients.

The U.S. approval of RADICAVA IV was based on the results of Study 19 (MCI186-19), a Phase 3 trial involving 137 participants. This study, which followed a randomized placebo-controlled format, found that patients treated with RADICAVA IV exhibited a significantly slower decline in physical function—2.49 fewer points on the ALS Functional Rating Scale-Revised (ALSFRS-R)—compared to those receiving a placebo (p=0.0013).

RADICAVA ORS provides the same medication as RADICAVA IV but in an oral suspension form, offering a different method of administration. According to clinical data, RADICAVA ORS and RADICAVA IV both help reduce the decline in physical function by approximately 33% over 24 weeks, as measured by the ALSFRS-R. The safety profile for RADICAVA IV was established in pooled placebo-controlled studies, including 184 patients who underwent 24-week treatment cycles. For RADICAVA ORS, the safety profile was demonstrated during a 6-month Phase 3 open-label clinical trial involving 185 patients. Common side effects included contusion, gait disturbance, headache, and fatigue.

To further validate the efficacy and safety of these treatments, MTPA has conducted real-world evidence (RWE) studies comparing RADICAVA IV-treated ALS patients with those not treated with RADICAVA. These studies focus on healthcare resource utilization and patient outcomes, showcasing MTPA's dedication to transparency and evidence-based practices.

In the U.S., RADICAVA IV and RADICAVA ORS have been administered to over 14,600 ALS patients, accounting for more than 1.8 million therapy days, and prescribed by over 2,300 healthcare providers. These treatments are supported by extensive data from various MTPA-sponsored clinical trials, post-hoc analyses, and RWE studies, with results published in over 40 peer-reviewed articles.

Since edaravone's initial approval as RADICUT® in Japan and South Korea in 2015, marketing authorizations have been obtained in multiple countries, including Canada, Switzerland, Indonesia, Thailand, Malaysia, and Brazil. In the U.S., RADICAVA and RADICAVA ORS are available through MTPA's network of specialty pharmacies and distributors.

MTPA has issued important safety information regarding RADICAVA and RADICAVA ORS. These drugs are contraindicated for patients with known hypersensitivity to edaravone or its inactive ingredients, as hypersensitivity reactions and anaphylaxis have been reported. Both formulations contain sodium bisulfite, which may cause allergic reactions, particularly in individuals with asthma. Common adverse reactions include contusion, gait disturbance, headache, and fatigue. There is also a potential risk of fetal harm based on animal studies, and patients are advised to report any adverse reactions to healthcare providers or regulatory authorities.

Mitsubishi Tanabe Pharma America, Inc., a subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), is dedicated to advancing its pharmaceutical pipeline and commercializing approved products in North America. Established by MTPC, one of the oldest pharmaceutical companies in the world, MTPA draws on a long history of innovation in the pharmaceutical industry to deliver hope to patients battling ALS and other illnesses.