Launch of Searchable Online Resource Coincides with Two-Year Anniversary of RADICAVA® (edaravone) FDA Approval
JERSEY CITY, N.J., May 6, 2019 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the availability of a new infusion care database within the ALS Care Locator platform available at www.RADICAVA.com. This new feature is designed to provide a convenient, searchable resource to help people with amyotrophic lateral sclerosis (ALS) and caregivers locate infusion treatment centers and in-home infusion services in their local areas.
“Information and resources are important to those seeking ALS care,” said Atsushi Fujimoto, President, MTPA. “We sincerely hope that expanding the reach of the ALS Care Locator will give more people in the ALS community direct access to search for services and coordinate therapy based on individual needs and healthcare provider treatment plan.”
The infusion services directory allows users to choose whether an infusion center or in-home infusion service is preferred, and then requests the patient’s location to generate a list of local services along with respective contact and insurance information, when available. To date, the ALS Care Locator includes over 614 infusion sites, 138 home infusion centers and 178 ALS healthcare providers, all of which users can also locate using the tool. MTPA plans to expand the platform which will be updated over time with additional resources and capabilities.
The ALS Care Locator allows anyone to search directly for ALS care resources, a capability previously only available through the product access program for RADICAVA® (edaravone), called Searchlight SupportTM. Nearly 4,000 Americans have been treated since the medicine became available in August 2017.
About RADICAVA® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS). 1 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.1,2,3
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 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.
About the ALS Care Locator
Infusion centers listed in the directory are not affiliated with Mitsubishi Tanabe Pharma America, Inc. (MTPA) and do not pay to be on the list. No feed or remuneration of any kind have been or will be exchanged for participation in the ALS Care Locator. Inclusion of an infusion center in the ALS Care Locator does not constitute a referral, recommendation, endorsement, or verification of credentials, qualifications, or abilities of the infusion center listed. Similarly, the absence of an infusion center’s name and information should not be construed as a negative comment from MTPA about the infusion center’s credentials, qualifications, or abilities.
MTPA, as well as its employees or agents, shall not be held liable for any damages or harm resulting from any use or reliance on information contained in the ALS Care Locator, and may modify, amend, remove or cancel the ALS Care Locator at any time without notice. For more information, please visit ALS Care Locator.
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.
Overview of Mitsubishi Tanabe Pharma Corporation 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. 4 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/.
- RADICAVA® U.S. Prescribing Information. August 2017.
- 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.
- Research by TOKYO SHOKO RESEARCH, LTD.