Mitsubishi Tanabe Pharma America Inc (MTPA) presented results from a post-hoc analysis assessing its Phase 3 edaravone study reviewing functional changes in both bulbar and limb onset patients with amyotrophic lateral sclerosis (ALS).
The 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,” says Gustavo A. Suarez Zambrano, MD, Vice President of Medical Affairs at MTPA, in a media release.
“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.
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 release explains.
[Source(s): Mitsubishi Tanabe Pharma America Inc, PR Newswire]