JERSEY CITY, N.J., September 30, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced four presentations on amyotrophic lateral sclerosis (ALS) will be shared as part of the Northeast Amyotrophic Lateral Sclerosis (NEALS) 19th Annual Meeting, being held virtually Sept. 30 – Oct. 1, 2020. The data provide deeper insight into U.S. experience with RADICAVA® (edaravone), as well as ongoing research and development efforts.
“We look forward to sharing research updates that reinforce our continued dedication to the ALS community, including exploring biomarkers that may help advance our understanding of this progressive disease,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “Mitsubishi Tanabe Pharma group companies remain committed to furthering the development of an investigative oral suspension formulation of edaravone potentially for people with ALS, and are currently gathering long-term safety and tolerability data through an ongoing global Phase 3 study.”
ALS data to be presented at NEALS include:
Development Program
An overview of the development program for an investigative oral formulation of edaravone will be shared in an encore poster presentation of Phase 1 pharmacokinetic (PK) results.
- Oral Suspension Formulation of Edaravone for Amyotrophic Lateral Sclerosis: Human Pharmacokinetics and Development Plan (Koji Takei, Mitsubishi Tanabe Pharma Corporation)
Biomarker Study
MTPA will present details on the REFINE-ALS study, for which MTPA aims to identify and measure specific biomarkers and clinical assessments in people with ALS.
- RADICAVA® (edaravone) Findings in Biomarkers from ALS (REFINE-ALS) (James Berry, M.D., Massachusetts General Hospital)
Real-World Data
An analysis examining real-world clinical outcomes of treatment with RADICAVA in people with ALS will be presented, based on 12-month data obtained from Soleo Health, a provider of home and alternative-site infusions and specialty pharmacy services in the U.S. Additionally, MTPA will present an analysis of data from a U.S. administrative claims database, Optum’s Clinformatics® Data Mart (CDM), including commercially insured ALS patients who received at least six months of continuous RADICAVA treatment.
- Real-World Treatment Patterns in Amyotrophic Lateral Sclerosis Patients Treated with IV Edaravone: 12-Months of Follow-up in Patients Receiving Treatment From a National Infusion Center (Melissa Hagan, Ph.D., MPH, MTPA)
- Demographic and Clinical Characteristics in Amyotrophic Lateral Sclerosis Patients Treated with IV Edaravone: Results From a US Administrative Claims Database (Melissa Hagan, Ph.D., MPH, MTPA)
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. It was established by MTPC to commercialize approved pharmaceutical products in North America. 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.1 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. For more information, go to http://www.mt-pharma.co.jp/.
About RADICAVA® (edaravone) IV
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) IV on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS).2 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 IV 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.
Media inquiries:
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com
1 Research by TOKYO SHOKO RESEARCH, LTD.
2 RADICAVA® U.S. Prescribing Information. August 2018.