New Post-Hoc Analysis of Phase 3 Study Examines Edaravone in ALS Patients with Bulbar and Limb Onset
Data Presented at 2020 Muscular Dystrophy Association
Annual Clinical & Scientific Conference
JERSEY CITY, N.J., March 24, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced the presentation today of a new post-hoc analysis assessing its Phase 3 edaravone study reviewing functional changes in both bulbar and limb onset patients with amyotrophic lateral sclerosis (ALS). This analysis of the Phase 3 study was shared during a virtual presentation as part of the 2020 Muscular Dystrophy Association Clinical & Scientific Conference.
“It’s motivating to see these results in both groups of patients,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “We hope this data analysis provides helpful insights for the ALS community, particularly healthcare providers serving patients experiencing bulbar symptoms, such as speech and swallowing difficulties, early on in their disease.”
This post-hoc analysis assessed edaravone on the rate of loss of physical function among bulbar (n=30) and limb onset (n=107) patients vs. placebo, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument that measures progression of disability in patients with ALS.1 ALSFRS-R data with bulbar onset patients were also analyzed based on whether the patients had a forced vital capacity (FVC) of either ≥80 percent (n=5) or <80 percent (n=21) at the end of 24 weeks in the clinical study.
This analysis was funded and conducted by 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. 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 one of the longest history of pharmaceutical companies in Japan. 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 — Immuno-inflammation, Diabetes and Kidney, Central Nervous System, Vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA. For more information, go to https://www.mt-pharma.co.jp/e/.
Mitsubishi Tanabe Pharma America
- Cedarbaum JM, Stambler N, Malta E, et al.TheALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci.1999;169(1-2):13-21.