エーザイ、「メトジェクト(R)皮下注ペン」（一般名：メトトレキサート）が日本においてペン型自動注入器注射剤の承認を取得

2024年02月16日 12:00:00
テクノロジー
JCN Newswire

東京, 2024年2月16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、以下エーザイ）とmedac GmbH（本社：ドイツ）の子会社である日本メダック株式会社（本社：東京都、代表取締役：入山博久、以下日本メダック）は、このたび、抗リウマチ剤であるメトジェクト皮下注の剤形追加として、ペン型自動注入器注射剤「メトジェクト®皮下注7.5mgペン0.15mL、同10mgペン0.20mL、同12.5mgペン0.25mL、同15mgペン0.30mL」（一般名：メトトレキサート）について、日本メダックが厚生労働省より製造販売承認を取得したことをお知らせします。2019年5月にエーザイとmedac GmbHが締結したライセンス契約に基づき、本剤の製造販売承認は日本メダックが保有し、販売はエーザイが担当します。

本剤は、ペン型自動注入器に日本において既承認のメトジェクト皮下注プレフィルドシリンジ製剤を内蔵した注射剤で、患者様の自己注射時の負担の軽減と安全性の向上を目的として開発されました。本剤は2ステップ（①キャップを外す、②皮膚に押し当てる）で自己注射が可能です。また、針カバーを内蔵することで投与前に針が見えなくなり、投与後も針カバーが自動的にロックすることで誤穿刺を防ぎます。

日本には約70～80万人の関節リウマチ患者様がおられると推定され、メトトレキサートは関節リウマチ治療において第一選択薬として使用されています1。エーザイと日本メダックは、本剤を関節リウマチ患者様の負担を軽減する治療選択肢としてお届けし、関節リウマチ患者様の多様なニーズの充足とベネフィット向上により一層貢献してまいります。

URL https://www.eisai.co.jp/news/2024/news202410.html

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