Posted by Michael Wonder on 05 Oct 2018
Health Canada approves Radicava (edaravone) for the treatment of ALS
5 October 2018 - Mitsubishi Tanabe Pharma Corporation announced today that Edaravone (US name: Radicava; Japan name: Radicut bag for I.V. Infusion 30 mg) was approved by the Health Canada for an indication of amyotrophic lateral sclerosis, a rapidly progressive, neurodegenerative disease on 3 October.
Granted under the Priority Review process, the Notice of Compliance authorisation was based on a clinical trial which the primary endpoint was a measurement utilising the amyotropic lateral sclerosis (ALS) Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.
