www.fdanews.com/articles/176379-japanese-drugmakers-als-candidate-shines-in-phase-3
Japanese Drugmaker’s ALS Candidate Shines in Phase 3
April 27, 2016
Japanese drugmaker Mitsubishi Tanabe Pharma says a candidate for Lou Gehrig’s disease hit its target in a Phase 3 trial.
The trial showed that MCI-186 met its primary efficacy endpoint of mean change in amyotrophic lateral sclerosis patient performance on the ALS Functional Rating after 24 weeks of treatment.
The drug received orphan drug-designation from the FDA and EMA in May 2015, but it has yet to be approved in either region.