Mitsubishi Tanabe Pharma Corporation announced 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 for RADICUT injection 30mg and RADICUT BAG for I.V. infusion in Japan.
RADICUT is a free-radical scavenger discovered by Mitsubishi Tanabe Pharma. In 2001, Mitsubishi Tanabe commenced clinical trials in Japan involving ALS patients. A series of clinical trials demonstrated that patients receiving RADICUT showed less functional loss than patients receiving a placebo.
ALS is a progressive and intractable disease characterized by Muscular atrophy and weakness. Disease progression is comparatively rapid, and if ventilators are used, survival time is said to typically be two to five years, however there is significant variation among individuals. Damage from oxidative stress caused by free radicals is thought to be one cause of the onset of ALS.
