News
Rozebalamine®, a New Treatment for Amyotrophic Lateral Sclerosis (ALS)
A research team that included Adjunct Professor Ryuji Kaji at Tokushima university Center for Research Administration and Collaboration and Professor Yuishin Izumi from Neurology in Tokushima university Hospital has conducted a phase III study to verify the efficacy and safety of high-dose methylcobalamin for patients in the early stages of amyotrophic lateral sclerosis (ALS).
In the Japan Early-stage Trial of Ultrahigh-Dose Methylcobalamin for ALS (JETALS), high-dose methylcobalamin significantly inhibited the progression of symptoms compared to a placebo, and the efficacy and safety of high-dose methylcobalamin for patients with early-stage ALS were confirmed.
Based on these results, Eisai Co., Ltd. filed an application for approval of Rozebalamin® (high-dose methylcobalamin) in January 2024, and on September 24, Eisai was approved to manufacture and market the drug to “inhibit the progression of dysfunction in amyotrophic lateral sclerosis (ALS).”
This is the third new drug for ALS in Japan and the first in about 9 years.