JERSEY CITY, N.J., December 4, 2019 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of a new analysis examining real-world clinical outcomes of treatment with RADICAVA® (edaravone) in people with ALS at the 30th International Symposium onALS/MND in Perth, Australia.
“We are pleased to share real-world data for RADICAVA with the ALS community, including clinicians who are considering treatment for their patients,” said Atsushi Fujimoto, President, MTPA. “The data offer a look at patient outcomes in ALS when treated with RADICAVA. This effort is a part of our continued commitment to the ALS community.”
To obtain real-world data on the use of RADICAVA, MTPA engaged Soleo Health, a provider of home and alternative-site infusions and specialty pharmacy services in the U.S., to share information from 163 patients receiving RADICAVA for at least three months. A retrospective analysis of the database looked at the average change in physical function, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R) score. The ALSFRS-R is a validated rating instrument for monitoring the progression of disability in people with ALS.1
“We utilized our SoleMetrics® proprietary clinical outcomes program to obtain a snapshot of the RADICAVA real-world experience,” said Drew Walk, Chief Executive Officer, Soleo Health. “Such data we collect offers distinct insights into the ALS patient journey that we believe can be valuable to providers and theALS community as we all seek to better help those impacted by this debilitating disease.” Soleo Health’s exclusive SoleMetrics program was used to collect data over time to gather intelligent outcomes throughout the patients’ journeys while they were under the direction of Soleo Health clinicians. SoleMetrics has the keen ability to collect disease-specific, drug-specific and patient-specific data for patients under its clinical care, providing real-world evidence for prescribers, manufacturers, payors and health systems.
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-pharmaamerica.com or follow us on Twitter, Facebook and LinkedIn. Overview of Mitsubishi Tanabe Pharma Corporation (MTPC)2
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company and has the longest history of any listed company in Japan.2 In accordance with the corporate philosophy of “contributing to the healthier lives of people around the world through the creation of pharmaceuticals,” the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016- 2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — autoimmune diseases, diabetes and kidney diseases, central nervous system diseases, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of RADICAVA. For more information, go to http://www.mt-pharma.co.jp/.
About Soleo Health
McKinney, Texas-based Soleo Health is an innovative national provider of complex specialty pharmacy and infusion services, administered in the home or at alternate sites of care. Soleo Health’s interdisciplinary team, comprised of experienced clinical pharmacists and registered nurses, utilizes a consistent patient management process, which leads to quantifiable clinical and economic value while improving patients’ experience. Soleo Health operates 20 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states, and is accredited by The Joint Commission.For more information, visit www.soleohealth.com or connect with Soleo Health on Facebook, Twitter and LinkedIn.
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). 3 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.4,5 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-thecounter 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 1-888-292-0058 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.
Mitsubishi Tanabe Pharma America
- Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci. 1999;169(1-2):13-21.
- Research by TOKYO SHOKO RESEARCH, LTD.
- 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.