Amgen Worldwide
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
オンラインリソース
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
疾患教育
重点領域
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
アムジェン株式会社（本社：東京、代表取締役社長：スザナ・ムルテイラ、以下「当社」）は、このたび、インスリン様成長因子-1受容体（IGF-1受容体）阻害剤であるテッペーザ®点滴静注用500mg（一般名：テプロツムマブ [遺伝子組換え]、以下「テッペーザ」）について、活動性甲状腺眼症（active Thyroid Eye Disease: aTED）の効能・効果で日本における製造販売承認を取得しましたので、お知らせいたします。
甲状腺眼症は、深刻で進行性かつ潜在的に失明の恐れがある希少な自己免疫性炎症性疾患です。眼球突出（眼球が前に出てくる）、複視（二重に見える）、目の痛み、目の発赤や充血、浮腫などのさまざまな眼症状を引き起こし、視機能および社会的心理面において患者さんの生活の質（QOL）が著しく損なわれます1。日本における甲状腺眼症の発症率は、人口10万人あたり7.3人（男性3.6人、女性13.0人）で、患者数は約3万5千人と推定されています2。
テッペーザは、通常、成人にはテプロツムマブ（遺伝子組換え）として初回は10 mg/kg を、2 回目以降は20 mg/kg を7 回、3 週間間隔で計8 回点滴静注する薬剤です。甲状腺眼症ではIGF-1受容体が過剰発現しており、テッペーザはIGF-1受容体を阻害することで、外眼筋および眼窩内脂肪組織の肥大や炎症を軽減し、眼球突出をはじめとする眼症状を改善させる効果が期待されます。この承認は、日本における中等度から重度の活動性甲状腺眼症患者に対するテッペーザの有効性、忍容性、安全性を評価する無作為化二重遮蔽プラセボ対照並行群間比較多施設共同第III相臨床試験（OPTIC-J）3の肯定的な結果に基づくものです。OPTIC-Jでは有効性の主要評価項目を達成し、24週時点で、プラセボ投与群（11%）と比較して、テッペーザ投与群では89%の患者において、臨床的に意味のある眼球突出（2 mm以上）の改善が認められました（p＜0.0001）。安全性プロファイルは、テッペーザのこれまでの臨床試験で確認されたものと一致しています。なお、テッペーザは日本で希少疾病用医薬品の指定を受けています。
当社代表取締役社長のスザナ・ムルテイラは次のように述べています。「テッペーザの承認は、日本における活動性甲状腺眼症の治療を大きく変革し、前進させる重要なマイルストーンとなります。甲状腺眼症は、眼の症状のみならず、患者さんの日常生活や社会生活の多くの側面に深刻な影響を与えています。この度、日本で初めての活動性甲状腺眼症治療薬となるテッペーザをお届けすることによって、患者さんのQOLの向上に貢献できることを大変嬉しく思います。」
また、久留米大学名誉教授、新古賀病院糖尿病・甲状腺・内分泌センターの廣松雄治 医師は次のように述べています。「甲状腺眼症に対しては、これまで疾患の根本原因に作用する治療薬が存在せず、高用量のステロイド投与や手術といった患者さんにとって負担のある治療が主流でした。今回、テッペーザが日本で製造販売承認されたことにより、活動性甲状腺眼症の患者さんに新しい治療選択肢を提供できることになりました。これは日本の甲状腺眼症診療をさらに進歩させる大きな出来事であると言えます。」
テッペーザは、2020年1月に初めての甲状腺眼症治療薬として米国で承認されました。その後、ブラジル、サウジアラビアで承認されており、欧州、英国、カナダ、オーストラリア、スイスなどで承認申請中です。また、現在日本においては、慢性期の甲状腺眼症を対象とした第 III相臨床試験が進行中です。この試験では、試験開始の2～10年前に甲状腺眼症と初めて診断され、CAS（臨床活動性スコア）が低い患者さんを対象としています。試験の詳細は、臨床研究等提出・公開システムのウェブサイト（実施計画番号jRCT2031220730）を参照してください。
製品概要
| 販売名： | テッペーザ®点滴静注用500mg |
| 一般名： | テプロツムマブ（遺伝子組換え） |
| 効能又は効果： | 活動性甲状腺眼症 |
| 効能又は効果に関連する注意： | 本剤投与時に、聴覚障害（難聴、聴力低下、耳管機能障害、耳管開放、聴覚過敏、耳鳴、鼓膜障害等）があらわれることがあり、重篤かつ不可逆的な事象も報告されている。添付文書「17.臨床成績」の項の内容を熟知し、臨床試験で対象とされた患者背景、並びに本剤の有効性及び安全性の試験結果等も十分に理解した上で、適用患者を選択すること。軽症の活動性甲状腺眼症患者を対象とした有効性及び安全性を指標とした臨床試験は実施していない。 |
| 用法及び用量： | 通常、成人にはテプロツムマブ（遺伝子組換え）として初回は10mg/kgを、2回目以降は20mg/kgを7回、3週間間隔で計8回点滴静注する。 |
※詳細は最新の添付文書をご覧ください。
アムジェン株式会社について
アムジェン株式会社は、世界最大規模の独立バイオテクノロジー企業である米国アムジェン社の日本法人です。アムジェン株式会社では、循環器疾患、がん、骨疾患、炎症・免疫性疾患、神経疾患、希少疾患を始めとするアンメット・メディカル・ニーズが高い領域に焦点を絞り、「To serve patients – 患者さんのために、今できるすべてを」というミッションのもと、臨床開発から販売までの活動を行っています。詳細については www.amgen.co.jp をご覧になるか、https://www.facebook.com/amgenjapan をフォローしてください。
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注意事項（アムジェン株式会社）
このニュースリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的とするものではありません。
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References