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MT Pharma America to Present Data on Investigational Edaravone and Amyotrophic Lateral Sclerosis at the 2017 American Academy of Neurology Annual Meeting
JERSEY CITY, N.J., April 20, 2017 /PRNewswire/ -- MT Pharma America, Inc. (MTPA) today announced it will present four abstracts at the 69th Annual Meeting of the American Academy of Neurology (AAN) in Boston. Presentations include data evaluating investigational edaravone as well as an analysis evaluating clinically relevant symptoms of amyotrophic lateral sclerosis (ALS) prior to diagnosis.
"The clinical data being presented at AAN continues to deepen our understanding of edaravone's role in helping slow the decline of physical function," said Joseph M. Palumbo, M.D., Vice President, Head of Medical Science and Translational Research, Mitsubishi Tanabe Pharma Development America, Inc.
Data to be highlighted from the edaravone clinical program include three post-hoc analyses of the Phase 3 MCI186-19 study, which evaluated treatment with investigational edaravone compared with placebo. A separate analysis looked at a U.S. claims database of more than 170 million patients and found potential predictors in patients who eventually were diagnosed with ALS.
MTPA-sponsored abstracts being presented at AAN include:
Edaravone Clinical Presentations:
- Edaravone (MCI-186) for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A Posthoc Analysis of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) by Domain and Individual Items
Abstract 130, Poster Session III, Tuesday, April 25, Exhibit Hall B1, 8:30 a.m. 5:30 p.m. ET
- Edaravone (MCI-186) for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A Posthoc Assessment of the 40-Item ALS Assessment Questionnaire (ALSAQ-40) by Domain
Abstract 116, Poster Session IV, Wednesday, April 26, Exhibit Hall B1, 8:30 a.m. 5:30 p.m. ET
- Cumulative Distribution of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Scores in a Phase 3 Study of Edaravone (MCI-186) for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A Posthoc Assessment
Abstract 110, Poster Session V, Thursday, April 27, Exhibit Hall B1, 8:30 a.m. 5:30 p.m. ET; Data Blitz Presentation: 12:30 p.m. 12:35 p.m. ET
- Use of Big Data Analytics for Early Diagnosis of Amyotrophic Lateral Sclerosis (ALS)
Abstract 119, Poster Session IV, Wednesday, April 26, Exhibit Hall B1, 8:30 a.m. 5:30 p.m. ET
Edaravone is an investigational drug in the U.S. and was discovered and developed by Mitsubishi Tanabe Pharma Corporation. Commercialization is being pursued in the U.S. by MT Pharma America. Mitsubishi Tanabe group companies began researching ALS in 2001 through a comprehensive clinical platform over a 13-year period. In 2015, edaravone was approved for use as a treatment for ALS in Japan and South Korea.
The U.S. Food and Drug Administration (FDA) accepted the Company's New Drug Application for edaravone on August 30, 2016, and a decision is anticipated by June 16, 2017, based on the Prescription Drug User Fee Act.
An estimated 5,000-6,000 Americans are diagnosed each year with ALS, a typically fatal and incurable disease that affects the nerve cells in the brain and the spinal cord.1,2,3 The majority of ALS patients die within two to five years of receiving a diagnosis, but progression of the disease can vary significantly.4 Initial symptoms can be subtle at first and it can take up to 12 to 14 months to be accurately diagnosed with ALS.5,6
About MT Pharma America
Based in Jersey City, N.J., MT Pharma America (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 the U.S. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners. For more information, go to www.mt-pharma-america.com or follow us on Twitter at https://twitter.com/MTPharmaUS.
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.7 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 16-20. 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. For more information, go to http://www.mt-pharma.co.jp/.
ALS Association. Quick Facts about ALS. http://www.alsa.org/news/media/quick-facts.html. Accessed April 12, 2017.
Marin B, Boumediene F, Logroscino G, et al. (2016). Variation in worldwide incidence of amyotrophic lateral sclerosis: a meta-analysis. Int J Epidemiol, 00:1-18.
National Institute of Neurological Disorders and Stroke. Amyotrophic Lateral Sclerosis (ALS) Information Page. https://www.ninds.nih.gov/disorders/all-disorders/amyotrophic-lateral-sclerosis-als-information-page. Accessed April 12, 2017.
Mehta P, Kaye W, Bryan L, et al. (2016). Prevalence of Amyotrophic Lateral Sclerosis ? United States, 20122013. MMWR Surveill Summ; 65(No. SS-8):112
ALS Therapy Development Institute. What is ALS. http://www.als.net/what-is-als/. Accessed April 12, 2017.
Brooks BR. (2000). Risk factors in the early diagnosis of ALS: North American epidemiological studies. Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders, 1:sup1, S19-S26
Research by TOKYO SHOKO RESEARCH, LTD.
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SOURCE MT Pharma America, Inc.
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