Mitsubishi Tanabe Pharma America, Inc. (MTPA) Stands with the ALS Community

JERSEY CITY, N.J., May 23, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) is aware of recent external challenges facing the amyotrophic lateral sclerosis (ALS) treatment landscape. We know firsthand the great need for ALS treatments and when there is a setback for one of us, the entire community is affected.

We want to reiterate that we remain focused on our mission to support the broader community through research, treatments, advocacy and patient resources.

We are dedicated to advancing our understanding of ALS through ongoing research, including continuing to evaluate the full potential of FDA-approved RADICAVA ORS^® (edaravone) and intravenous (IV) RADICAVA^® (edaravone). The U.S. approval of RADICAVA IV was based on Study 19 (MCI186-19), a randomized placebo-controlled Phase 3 study which was conducted prospectively in 137 people who met criteria identified from an exploratory analysis of the Phase 3 MCI186-16 study. In Study 19, on average, patients on RADICAVA^® lost 2.49 fewer points on the ALSFRS-R vs those in the placebo arm (p=0.0013).¹

RADICAVA ORS^® offers the same drug as RADICAVA IV^® in a different formulation.^1,2 RADICAVA IV and RADICAVA ORS help slow the loss of physical function in patients with ALS by 33 percent vs. placebo, measured over 24-weeks by the ALS Functional Rating Scale-Revised (ALSFRS-R).^1,2 The safety profile of RADICAVA IV was demonstrated in pooled placebo-controlled trials in which 184 patients with ALS were administered RADICAVA IV (60 mg) in 24-week treatment cycles.¹ The safety profile of RADICAVA ORS was demonstrated in a 6-month, Phase 3, open-label clinical trial in 185 patients.¹ In addition to contusion, gait disturbance, and headache reported with RADICAVA, fatigue was observed in 7.6% (14/185) of patients receiving RADICAVA ORS^®.¹ Please see Important Safety Information below and Full Prescribing Information here.

Over the past years, we have conducted real-world evidence (RWE) studies* to evaluate RADICAVA IV-treated ALS patients with non-RADICAVA patients.¹ We are also gathering data on related factors, including healthcare resource utilization and patient outcomes. We believe the data gathered from RWE underscores our commitment to transparency and evidence-based practices.

To date, in the U.S., RADICAVA IV and RADICAVA ORS have been used to treat over 14,600 people with ALS, with over 1.8-million days of therapy, and have been prescribed by more than 2,300 HCPs.^4-6 RADICAVA ORS and RADICAVA IV have been supported by a robust set of data from multiple MTPA-sponsored clinical trials, post-hoc analysis and RWE studies evaluating the efficacy and safety. These results have been published in over 40 peer-reviewed articles.

In 2015, edaravone was approved as RADICUT^® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA^® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT^® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. In the U.S., RADICAVA and RADICAVA ORS are available via MTPA's network of specialty pharmacies and specialty distributors.

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.

Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.

Media inquiries:
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* These studies are limited only to patients with ALS who have commercial health coverage. Real-world data analyses have inherent limitations and are not intended to replace prospective clinical trials.

¹ RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
² Shimizu H, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197.
³ Brooks, B, et al. Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysis. eClinicalMedicine. 2022; 52: 101590.
⁴ Data on file, MTPA.
⁵ Data on file, MTPA.
⁶ Data on file, MTPA.

SOURCE Mitsubishi Tanabe Pharma America