Novel ALS therapy edaravone considered for approval in Europe

The European Medicines Agency has accepted a filing from Japan’s Mitsubishi Tanabe Pharma (TYO: 4508) to market edaravone for  amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease.

Marketed in Japan as Radicut and in the USA as Radicava, the therapy was approved by the US Food and Drug Administration last year - the first new treatment in two decades - after officials at the agency encouraged Mitsubishi Tanabe to submit a filing.

In the USA, the pre-discount price for an annual course of infusions is reportedly around $145,000, well above the some $35,000 the therapy was originally priced at in Japan.