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Press release
2022年05月27日 10時00分
Source:
Eisai
エーザイ、メコバラミンの高用量製剤がALSの病態及び機能障害の進行抑制を予定される効能又は効果として、厚生労働省より希少疾病用医薬品に指定
東京, 2022年05月27日 - (JCN Newswire) - エーザイ株式会社（本社：東京都、代表執行役 CEO：内藤晴夫）は、このたび、メコバラミンの高用量製剤について、筋萎縮性側索硬化症（Amyotrophic Lateral Sclerosis: ALS）の病態及び機能障害の進行抑制を予定される効能又は効果として、厚生労働省より希少疾病用医薬品に指定されたことをお知らせします。
ALS は、進行性の難治性神経変性疾患で、アンメット・メディカル・ニーズが極めて高い難病です。日本における ALS 患者様数は約 1 万人と推定されています。
高用量メコバラミンについては、国立大学法人徳島大学（以下、徳島大学）の梶龍兒特命教授（主任研究者）、徳島大学大学院医歯薬学研究部臨床神経科学分野 和泉唯信教授（治験調整医師）らが主導した発症早期の ALS 患者様に対する高用量メコバラミンの有効性、安全性の検証を目的とした「高用量メチルコバラミン（メコバラミン）の筋萎縮性側索硬化症に対する第III相試験-医師主導治験-」（The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS: 以下、JETALS）において良好な臨床試験結果が得られました。本試験結果を受けて、当社は日本における ALS に対する新薬承認申請に向けた作業を開始し、2023 年度中の新薬承認申請を予定しています。
当社は、神経領域を重点疾患領域と位置づけており、新たな薬剤の開発に注力しています。神経領域におけるアンメット・メディカル・ニーズの充足と患者様とそのご家族のベネフィット向上により一層貢献してまいります。
本リリースの詳細は下記をご参照ください。
https://www.eisai.co.jp/news/2022/news202240.html
概要：エーザイ株式会社
詳細は www.eisai.co.jp をご覧ください。
Source: Eisai
セクター: バイオテック
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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