JERSEY CITY, N.J., October 9, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced a poster presentation of a Phase 3 edaravone study post-hoc analysis assessing functional changes in bulbar- and limb-onset patients with amyotrophic lateral sclerosis (ALS). The analysis was shared as part of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2020 Virtual Annual Meeting.
“We are pleased to share this post-hoc analysis of patients with limb-onset ALS and those who experienced early bulbar symptoms, such as speech and swallowing difficulties,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “This analysis adds to our knowledge of treatment with edaravone. We remain committed to furthering our understanding of this progressive disease and hope the information shared during AANEM is insightful for the ALS community.”
This post-hoc analysis assessed data from the Phase 3 clinical trial by looking at the effect of edaravone on patients with bulbar- (n=30) and limb-onset (n=107) patients vs. placebo from baseline at week 24 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. The subgroups in the post-hoc analysis were not pre-specified in the clinical trial, but were rather developed for the analysis itself.
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. 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.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. For more information, go to https://www.mt-pharma.co.jp/e/.
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- Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci.1999;169(1-2):13-21.
- Research by TOKYO SHOKO RESEARCH, LTD.