Presentations Include U.S. Real-World Evidence on Edaravone for ALS
JERSEY CITY, N.J., December 2, 2019 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced six presentations on amyotrophic lateral sclerosis (ALS), including new results examining real-world clinical outcomes of treatment with edaravone in people with ALS, at the 30 th International Symposium on ALS/MND, December 4-6 in Perth, Australia.
“We are pleased to present this additional data, which we hope will provide important insights as we work to increase understanding of ALS and the patient journey,” said Atsushi Fujimoto, President, MTPA. “It is an honor to join the many accomplished researchers, scientists and neurologists attending this year’s International Symposium, as we all work toward a shared goal of battling this terrible disease.”
The following posters will be presented on Thursday, Dec. 5, from 10:30 – 11:30 AM (AWST):
Real World Data
- Real-World Evidence of RADICAVA® (edaravone) for Amyotrophic Lateral Sclerosis from a National Infusion Center Database in the United States
Abstract CMS-29, Poster Session A, Theme 13 (Clinical management and support) - Evidence for Generalizability of Edaravone Efficacy Using a Novel Machine-Learning (ML) Risk-Based Analysis Tool
Abstract EPI-13, Poster Session A, Theme 1 (Epidemiology and informatics) - Retaining Physical Function in Amyotrophic Lateral Sclerosis With Edaravone: Post hoc Analysis of Pivotal Study MCI186-19
Abstract CLT-39, Poster Session A, Theme 9 (Clinical trials and trial design)
ALS Patient Journey
- The Influence of Clinical Study Inclusion Criteria on Baseline Characteristics and Disease Progression in Amyotrophic Lateral Sclerosis
Abstract CLT-07, Poster Session A, Theme 9 (Clinical trials and trial design) - Machine Learning Model Using Insurance Claims Data to Help Predict Future ALS Diagnosis
Abstract EPI-10, Poster Session A, Theme 1 (Epidemiology and informatics)
Research & Development
- Engaging ALS Research Ambassadors to Help Design the REFINE-ALS Biomarker Study
Abstract CLT-04, Poster Session A, Theme 9 (Clinical trials and trial design)
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’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in North America. It was established by MTPC to commercialize approved pharmaceutical products in North America with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com or follow us on Twitter and Facebook.
About RADICAVA® (edaravone)
The U.S. Food and Drug Administration approved RADICAVA® (edaravone) on May 5,2017, as a treatment for amyotrophic lateral sclerosis (ALS). In a pivotal trial, people given RADICAVA experienced a 33 percent slower rate of decline in the loss of physical function, compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in people with ALS.2,3
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. MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.
IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:
- have asthma.
- are allergic to other medicines.
- are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of RADICAVA?
- RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
- Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
- RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
- Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
- Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.
The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com.
Media inquiries:
Mitsubishi Tanabe Pharma America
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com
- RADICAVA® U.S. Prescribing Information. August 2018.
- Simon, N. G., Turner, M. R., Vucic, S., Al-Chalabi, A., Shefner, J., Lomen-Hoerth, C., & Kiernan, M. C. (2014). Quantifying Disease Progression in Amyotrophic Lateral Sclerosis. Annals of Neurology, 76(5), 643–657. http://dx.doi.org/10.1002/ana.24273
- The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group (2017). Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurology. 16(7), 505-512.