Mitsubishi Tanabe pulls Radicava MAA for ALS in the Europe

Mitsubishi Tanabe Pharma (TYO: 4508; MTPC) announced today the withdrawal of the Marketing Authorization Application (MAA) of Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU).

The edaravone MAA was submitted in 30 April 2018 by Mitsubishi Tanabe Pharma Europe, the MTPC R&D subsidiary in the EU. Edaravone (named Radicut BAG for IV Infusion 30mg in Japan) is an intravenous treatment for ALS, a rapidly progressive neurological disease.

Edaravone has been approved for treatment of ALS in Japan, South Korea, the USA, Canada and Switzerland, based on the results from a six-month placebo-controlled study in Japanese ALS patients, in which the primary endpoint was the ALS functional rating scale (ALSFRS-R), a measurement of functional loss in daily living activities in ALS patients.