Oral form of edaravone closer to Swiss market

Swiss regulator Swissmedic has accepted the filing for an investigational oral suspension formulation of Mitsubishi Tanabe’s (TYO: 4508) edaravone in amyotrophic lateral sclerosis (ALS).

The oral suspension contains the same active ingredient as edaravone for intravenous infusion, which is marketed in Switzerland under the brand Radicava, and as Radicut in Japan.

This Marketing Authorization application was submitted based on both the 24-week results from the global Phase III trial evaluating the safety and tolerability of the new formulation in ALS, and the clinical pharmacology study comparing the pharmacokinetics of the oral suspension and the intravenous infusion.