Edaravone approved in Japan for the treatment of ALS

On June 26, 2015, the regulatory agency of Japan, the Pharmaceutical and Medical Device Agency (PMDA), has granted marketing approval for the use of Edaravone for the treatment of ALS in Japan.

The press release published by Mitsubishi Tanabe Pharma Corporation on June 26, 2015, reads the following:

"Mitsubishi Tanabe Pharma Corporation announced today that it has received approval of a partial change in manufacturing and marketing approval items related to an additional indication and dosage/usage for Amyotrophic Lateral Sclerosis (ALS) for Edaravone inj. 30mg and Edaravone bag for I.V. infusion 30mg in Japan.

Edaravone is a free-radical scavenger discovered by Mitsubishi Tanabe Pharma. In 2001, Mitsubishi Tanabe Pharma commenced clinical trials in Japan involving ALS patients. A series of clinical trials demonstrated that patients receiving Edaravone showed less functional loss than patients receiving a placebo.

Edaravone is not yet approved to treat ALS in other countries than Japan. However, Edaravone was already approved in Japan as a treatment of acute ischemic stroke. Edaravone is already available via everyone.org, and can be acquired when a doctor's prescription is provided.

References

• Radicut Approved for ALS in Japan
  ALS Therapy Development Institute, June 2015

Articles addressing the safety and efficacy of Edaravone

• Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
  Abe K, Itoyama Y, Sobue G, et al., Lateral Sclerosis & Frontotemporal Degeneration. 2014;15(7-8):610-617. doi:10.3109/21678421.2014.959024.
• Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (Phase II study).
  Yoshino H, Kimura A., Amyotroph Lateral Scler. 2006; 7:241–5. PMID: 17127563.