Mitsubishi Tanabe Pharma America Reports 48-Week P-III Trial (MT-1186-A01) Results of Radicava ORS (edaravone) for Amyotrophic Lateral Sclerosis
- 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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