Posted: October 15, 2021 at 9:00 a.m. EDT
JERSEY CITY, NJ, October 15, 2021 / PRNewswire / – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that two abstracts on amyotrophic lateral sclerosis (ALS) will be presented during the 146e American Neurological Association Annual Meeting (ANA2021), held virtually October 17-19.
“We are delighted to share the design of the first global Phase 3 investigational oral edaravone study as an exciting step in evaluating the use of this formulation in patients with ALS,” said Gustavo A. Suarez Zambrano, MD, vice president of medical affairs at MTPA. “Our commitment to the ALS community goes beyond the study of treatments and includes our determination to understand the real impact of this devastating disease on patients and caregivers. We hope that the actual results presented at ANA2021 will provide insight into the significant impact that ALS can have on close family members, and in turn help inform the development of appropriate and needed support services. “
MTPA posters will be available for viewing throughout the ANA2021 meeting. Key data to present include:
Oral Edaravone Development Program
An overview of the study design and basic characteristics for the world phase 3, an open-label, multicenter study (MT-1186-A01) evaluating the long-term safety and tolerability of an investigational oral suspension of edaravone will be presented. The study, which is sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), is evaluating 213 patients with ALS at approximately 50 sites in the United States, Canada, Europe and Japan during the 48 weeks of treatment.
- Phase 3, Open-label, Multicenter Safety Study of Oral Edaravone for 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis: Study Design and Baseline (MT-1186-A01) (Poster # LB-449; Manabu Hirai, Mitsubishi Tanabe Pharma Corporation)
Real world data
An analysis examining the humanistic and economic burden experienced by caregivers of patients with ALS will be presented based on data from the Adelphi ALS Disease Specific Program ™, a one-time survey of neurologists and their patients in consultation with ALS, Between july 2020 and March 2021.
- Burden on caregivers of patients with amyotrophic lateral sclerosis in United States (Poster # 234; Melissa Hagan, Ph.D., MPH, MTPA)
MT-1186 is an investigational oral suspension of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers in collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered at Osaka, Japan. In May 2019, the MTP group companies have completed a series of phase 1 studies of the administration of the oral suspension and intravenous formulations of edaravone in healthy volunteers. More information on the oral edaravone development program is available at ClinicalTrials.gov (NCT04165824 and NCT04577404).
About Mitsubishi Tanabe Pharma America, Inc.
Situated at Jersey City, New Jersey, Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), the 100% owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC for market approved pharmaceutical products. in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Ossaka, the birthplace of from Japan pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing its business operations under the mission of “Creating Hope for All Facing Disease” and has defined the corporate vision for 2030 (VISION 30): “To be a healthcare company that provides optimal therapy for each individual.” As part of the vision for 2030, the MTPC is prioritizing work on “medicine precision ”to create effective preventive therapies and methods by identifying patient populations with high potential for efficacy and safety, focusing on pathological areas of the central nervous system and immunoinflammation. , MTPC strives to develop “solutions around the pill” to address specific patient concerns based on therapeutic medicine, including disease prevention, pre-symptomatic care, a prevention of worsening and prognosis. MTPC is a member of the Mitsubishi Chemical Holdings group. For more information, visit https://www.mt-pharma.co.jp/e/.
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