FDA Approves Radicava, First New ALS Therapy in 22 Years

The first treatment for amyotrophic lateral sclerosis (ALS) in more than two decades, Radicava (edaravone), has been approved by the  U.S. Food and Drug Administration and will soon be available to patients. The May 5 FDA decision, hailed by physicians and ALS advocates, brings hope to the ALS community that treatment development, after a…

MT Pharma Presents Data on Edaravone for ALS at 2017 AAN Meeting

The amyotrophic lateral sclerosis (ALS) investigational drug edaravone will be the focus of four presentations by MT Pharma America in Boston. The presentations, which include data on edaravone and an analysis evaluating clinically relevant symptoms of ALS, are taking place at the 69th Annual Meeting of the American…

FDA Accepts Pharma’s New Drug Application for ALS Therapy Edaravone

The U.S. U.S. Food and Drug Administration (FDA) has accepted Mitsubishi Tanabe Pharma’s new drug application (NDA) for edaravone as a treatment for amyotrophic lateral sclerosis (ALS). A decision regarding the intravenous treatment is expected by June 16, 2017, based on the U.S. Prescription Drug User Fee Act. If it is…

Clinical Data of Promising ALS Drug Edaravone Presented at AAN Annual Meeting

Results from the Phase 3 trial of edaravone (MCI-186) in amyotrophic lateral sclerosis (ALS) were presented by Mitsubishi Tanabe Pharma Corporation at the 68th Annual Meeting of the American Academy of Neurology held April 15-21 in Vancouver, British Columbia. The Phase 3 MCI-186-19 clinical study has reportedly met its primary efficacy endpoint of mean change…