Edaravone was approved in Japan in 2015, and in the U.S. in 2017, based primarily on positive results of a single clinical trial in early-stage ALS patients conducted in Japan.
Edaravone was approved in Japan in 2015, and in the U.S. in 2017, based primarily on positive results of a single clinical trial in early-stage ALS patients conducted in Japan.
Edaravone has been available in Japan since 2003 for the treatment of acute stroke, but also showed promise in mouse models for ALS. An initial randomized controlled trial in patients with ALS did not show benefit for all patients, although a subgroup of patients in the earliest disease phase did benefit. A subsequent trial compared edaravone plus riluzole versus riluzole alone in patients with early-stage ALS who were free of substantial respiratory muscle weakness and who had progressed over a 3-month observation period. This study showed a 33% slowing in the rate of disease progression over a 6-month treatment period.
Add your comment