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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.

 

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