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).
JERSEY CITY, N.J., Oct. 9, 2020 /PRNewswire/ -- 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. Overview of Mitsubishi Tanabe Pharma Corporation Media inquiries: 1 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. View original content to download multimedia:http://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-announces-poster-presentation-of-als-data-at-american-association-of-neuromuscular--electrodiagnostic-medicine-aanem-2020-meeting-301149061.html SOURCE Mitsubishi Tanabe Pharma America, Inc. |