Press Release

Mitsubishi Tanabe Pharma America Honors Third Anniversary of
RADICAVA® (Edaravone) in the U.S. & Company’s Support of ALS Community

JERSEY CITY, N.J., August 6, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced updates related to the company’s commitment to the amyotrophic lateral sclerosis (ALS) community, in celebration of the third anniversary of the U.S. availability of RADICAVA® (edaravone).

“Throughout the last three years, we have been motivated by the strength and determination of the ALS community,” said Atsushi Fujimoto, President, MTPA. “This anniversary comes at a time when COVID-19 has impacted so many, and now more than ever we remain focused on our mission of helping as many patients as possible. We are committed to doing what we can to support the evolving needs of ALS patients, caregivers and healthcare providers during the pandemic.”

As part of MTPA’s ongoing work to support the ALS advocacy community, the company has sponsored a Muscular Dystrophy Association (MDA) educational webinar series covering multiple pandemic-related topics, such as what ALS patients can expect from virtual medical visits.

“We’re delighted to collaborate with MTPA, a great supporter of educational programming in ALS. MTPA has sponsored a wide range of high-impact educational programs for patients, families, caregivers and professional audiences this year,” said Lynn O’Connor Vos, President and CEO of MDA. “We look forward to continuing this partnership for many years to come.”

Additional MTPA recent efforts to help the community include:

  • To address healthcare provider (HCP) office needs driven by the COVID-19 pandemic and remote work situations, MTPA established new processes to enable HCPs to use electronic fax systems and DocuSign® to send the completed Benefits Investigation and Enrollment Forms for their patients, in addition to the standard submission options.
  • A COVID-19 resource page has been added to the MTPA corporate website to help answer questions that patients may have about accessing treatment during the pandemic.
  • MTPA recently launched the RADICAVA JourneyMateTM program offering live nurse educational phone support for ALS patients and caregivers to help answer questions about the disease and treatment. For more information, call 1-855-4-JRNY-M8, or 1-855-457-6968, from 9 a.m. to 9 p.m. ET Monday – Friday. The JourneyMate program does not give medical advice.
  • To help raise awareness about the impact of ALS on the veterans community, MTPA shared this patient story.
  • The ALS Care Locator online tool continues to be expanded, and now has more than 270 HCPs and 1,019 infusion centers listed.
  • Over the last year, MTPA launched the REFINE-ALS study which aims to identify biomarkers that might serve as quantifiable biological nonclinical measures of edaravone effects in ALS.

More than 5,000 U.S. patients have received RADICAVA since it became available on August 8, 2017. In addition, more than 1,300 HCPs have prescribed the treatment in that time.1

“We are privileged to have the opportunity to help the ALS community and look forward to continuing our efforts to fight this this terrible, debilitating disease,” Fujimoto added.

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, Facebook and LinkedIn.

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 with one of the longest histories of pharmaceutical companies 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 — immune-inflammation diseases, diabetes and kidney, central nervous system, 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 MTDA. For more information, go to http://www.mt-pharma.co.jp/.

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-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.

All company, product and trade names or other trade or service marks are the property of their respective owners.

Media inquiries:
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com


1 Mitsubishi Tanabe Pharma America Inc., Data on File as of August 2020. Based on internal data not independently verified.

2 Research by TOKYO SHOKO RESEARCH, LTD.

3 Research by TOKYO SHOKO RESEARCH, LTD.

4 RADICAVA® U.S. Prescribing Information. August 2018.

5 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