JERSEY CITY, N.J. March 1, 2024 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of five abstracts in amyotrophic lateral sclerosis (ALS) at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held in Orlando, Fla., March 3-6.
“We look forward to this year’s MDA conference where we will share findings from our ongoing Phase 4 REFINE-ALS biomarker study and results from multiple real-word studies in ALS, including analyses of treatment with RADICAVA ORS® (edaravone) and RADICAVA® (edaravone),” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “These presentations reinforce our commitment to making a positive impact on the ALS community by better understanding disease markers and outcomes and providing important information on our treatment options for clinical practice.”
MTPA’s posters will be showcased in the exhibit hall from March 3-5, 6:00-8:00 p.m. ET and viewable on the virtual platform during the conference. Presentations include:
REFINE-ALS Biomarker Study
Interim results will be presented from the ongoing Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effects of edaravone in ALS, as well as evaluate clinical outcomes in real-world settings, conducted in collaboration with the Neurological Clinical Research Institute at Massachusetts General Hospital.
- Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (James Berry, M.D., M.P.H.; Mass General Hospital)
Real-World Data
New preliminary data will be shared on demographics, characteristics and treatment combinations in people with ALS, utilizing U.S.-based administrative claims data from Optum’s de-identified Clinformatics® Data Mart (CDM). Additionally, updates from an ongoing, prospective study evaluating slow vital capacity (SVC) using in-clinic and in-home, portable spirometry will be presented. MTPA will also present an interim analysis of treatment patterns and clinical and patient-reported outcomes with RADICAVA, based on data from the ALS/Motor Neuron Disease Natural History Consortium multidisciplinary, clinic-based registry.
- Preliminary Analysis of Treatment Combinations in Patients with Amyotrophic Lateral Sclerosis Enrolled in an US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S; MTPA)
- Internet-Supervised Home-Based Slow Vital Capacity (SVC) Spirometry through Telemedicine in Amyotrophic Lateral Sclerosis – Prospective Multi-Center Observational Study (Eufrosina Young, M.D.; State University of New York Upstate Medical University)
- Treatment Patterns and Outcomes of Intravenous Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium (Malgorzata Ciepielewska, M.S.; MTPA)
Additionally, initial findings from a study sponsored by Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) will be presented providing insight into real-world demographics and characteristics of people with ALS treated with RADICAVA, based on de-identified data being collected from individuals enrolled in the Canadian MTP-Patient Support® program for up to four years with four pre-planned analyses.
- Real-World Evidence on Treatment Retention, Safety, and Tolerability of Edaravone in Canadian Patients With Amyotrophic Lateral Sclerosis (Dung Pham, PhD; MTPA-CA)
About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily 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. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. 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) and Malaysia (December 2021). 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. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 14,000 people with ALS, with over 1.6-million days of therapy, and have been prescribed by over 2,200 HCPs.2-4
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:
Media_MTPA@mt-pharma-us.com
1RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
2Data on file. Mitsubishi Tanabe Pharma America, Inc.
3Data on file. Mitsubishi Tanabe Pharma America, Inc.
4Data on file. Mitsubishi Tanabe Pharma America, Inc.