The P-III trial (MT-1186-A01) evaluating the long-term safety and tolerability of Radicava ORS (edaravone) in 185 patients with ALS for ~48wks. of treatment across 50 sites in the US, Canada, EU, and Japan. The study was funded and conducted by MTPA and MTDA
The results showed that Radicava ORS was well tolerated with no new safety signals. The study results were published in Muscle & Nerve, no serious TEAEs were reported, the discontinuation rate during the treatment period was 25%, and TEAEs led to treatment discontinuation was 8.6%. These results were based on the 24wk. results
Additionally, Radicava ORS was approved in the US on May 2022, as an oral suspension form of edaravone
Ref: PRNewswire | Image: Mitsubishi Tanabe
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