Presentations include new data from clinical and real-world evaluations of RADICAVA ORS® (edaravone) and RADICAVA® (edaravone)
JERSEY CITY, N.J. October 4, 2023 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that eight presentations in amyotrophic lateral sclerosis (ALS) will be shared at the 22nd Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting, being held in Clearwater, Fla., from October 4-6.
“We look forward to sharing several presentations at NEALS that demonstrate our progress in ALS research and underscore our commitment to understanding treatment outcomes for people living with this disease,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “From the continued evaluation of RADICAVA ORS® (edaravone) and RADICAVA® (edaravone) with real-world and patient-reported insights to exploration of home-based respiratory monitoring, we remain steadfast in our efforts to deepen our understanding of ALS and the impact of our treatment options.”
MTPA’s posters will be viewable throughout the conference. Presentations include:
A preliminary analysis of demographics and clinical characteristics in people with ALS being treated with RADICAVA ORS, utilizing U.S.-based administrative claims data from Optum’s Clinformatics® Data Mart (CDM), will be presented. Additional presentations include results from a pre-planned futility analysis – conducted by an independent data monitoring committee (IDMC) – of the global, multi-center, double-blind, Phase 3b MT-1186-A02 study of oral edaravone, as well as study design details from its extension study, MT-1186-A04, comparing two dosing regimens for oral edaravone to evaluate its continued efficacy and safety in ALS.
- A Preliminary Analysis of Oral Edaravone-Treated Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA)
- Phase 3b Study MT-1186-A02 of a Daily Dosing Regimen of Oral Edaravone Compared With the FDA-approved On/Off Regimen, Over 48 Weeks in Patients With Amyotrophic Lateral Sclerosis: An Update on a Pre-specified Futility Analysis (Steve Apple, M.D.; MTPA)
- Phase 3b Extension Study Evaluating Superiority of Daily vs Approved On/Off Oral Edaravone Dosing in Patients With Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Phase 4 REFINE-ALS Biomarker Study
Results from an interim analysis of the prospective, observational, longitudinal, multi-center Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effect of intravenous (IV) RADICAVA in ALS, as well as evaluate clinical outcomes in real-world settings, will be presented. REFINE-ALS is a NEALS-affiliated clinical trial sponsored by MTPA and conducted in collaboration with the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH).
- Interim Analysis of the Radicava/Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (Steve Apple, M.D.; MTPA)
Additional Real-World Data
Presentations include an interim analysis of treatment patterns and clinical and patient-reported outcomes with RADICAVA, based on data from the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) multidisciplinary, clinic-based registry. Additionally, updates from a prospective study evaluating slow vital capacity (SVC) in erect-seated (eSVC) and supine (sSVC) positions using in-clinic conventional and in-home, portable spirometry will be presented.
- Real-World Evidence on Treatment Patterns, Clinical Outcomes, and Patient-Reported Outcomes of Intravenous Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium Registry Database (Malgorzata Ciepielewska, M.S.; MTPA)
- Internet-Supervised Home-Based Spirometry through Telemedicine in Amyotrophic Lateral Sclerosis (Eufrosina Young, M.D.; State University of New York Upstate Medical University)
Additionally, study design details from two studies sponsored by Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) will be presented, including a real-world survival analysis evaluating the effectiveness of edaravone on tracheostomy-free survival in people with ALS and a real-world evidence study assessing treatment retention, safety and tolerability in edaravone-treated individuals, based on de-identified data from the Mitsubishi Tanabe Pharma-Patient Support™ (MTP-PS) program.
- Real-World Survival Effectiveness of Edaravone in Amyotrophic Lateral Sclerosis: A Propensity Score Weighted, Registry-based, Canada-wide Cohort Study (Agessandro Abrahao, M.D., M.S.; Sunnybrook Health Sciences Centre and University of Toronto)
- Real-World Evidence on Treatment Retention, Safety, and Tolerability of Edaravone in Canadian Patients With Amyotrophic Lateral Sclerosis (Dung Pham, Ph.D.; MTP-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 12,000 people with ALS, with over 1.45-million days of therapy, and have been prescribed by over 2,100 HCPs.2-4
IMPORTANT SAFETY INFORMATION
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.
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.
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.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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/.
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
2 Data on file. Mitsubishi Tanabe Pharma America, Inc.
3 Data on file. Mitsubishi Tanabe Pharma America, Inc.
4 Data on file. Mitsubishi Tanabe Pharma America, Inc.