Data will be presented from eight abstracts spanning preclinical to real-world analyses of RADICAVA® (edaravone)
JERSEY CITY, N.J., June 5, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced eight presentations at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 Annual Meeting being held in Stockholm, Sweden from June 17-20, 2024. The presentations will cover a wide range of translational research in amyotrophic lateral sclerosis (ALS), including the extension study results from the pivotal Phase 3 trial (MT-1186-A01) that contributed to RADICAVA® (edaravone) U.S. approval.
"We're encouraged by the wide range of translational research MTPA will be presenting at ENCALS this year," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "From two preclinical studies on RADICAVA's mechanism of action to real-world evidence generated during our post-marketing analysis, we are dedicated to providing valuable insights for researchers, healthcare providers and the ALS community."
RADICAVA ORS Results
Final data from the global, multi-center, double-blind, Phase 3b study MT-1186-A02 will be presented, including the post-marketing study evaluated an investigational once-daily dosing regimen of RADICAVA ORS® (edaravone) compared to the FDA approved on/off regimen administered in 28-day cycles in people with ALS over 48 weeks. In addition, full results will be presented from the Phase 3 open-label safety extension (MT-1186-A03) of RADICAVA ORS over 96 weeks.
Real-World Data
Results will be presented 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 edaravone in ALS, as well as evaluate clinical outcomes in real-world settings. In addition, data will be presented evaluating treatment patterns, clinical outcomes and survival of RADICAVA-treated people living with ALS in the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) registry.
Real-World Data from Optum Clinformatics® Data Mart
A preliminary analysis will be presented highlighting demographics, clinical characteristics and treatment patterns in people with ALS. The analysis utilized U.S.-based administrative claims data from electronic health records found in Optum's Clinformatics Data Mart. Separately, a preliminary analysis will be presented on healthcare resource utilization of people living with ALS who were treated with RADICAVA ORS.
Preclinical Data
Findings will be presented from a preclinical study demonstrating the effect of edaravone on spinal motor neurons derived via induced pluripotent stem cells (iPSC) created from an ALS patient carrying the A382T mutation in TDP-43, a key protein in ALS pathogenesis. In addition, results on the role of edaravone on the modulation of glutamate-mediated hyperexcitability in spinal motor neurons using an animal model of ALS will be presented.
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). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. 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), 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. To date, in the U.S., RADICAVA 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 over 2,300 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
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.
SOURCE Mitsubishi Tanabe Pharma America