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「アムジェン」）は、本日、活動性甲状腺眼症（active Thyroid Eye Disease: aTED）を効能・効果とした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」）の販売を開始したことをお知らせします。
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。「甲状腺眼症においては、長らく新しい治療法が求められてきました。この疾患では、眼球突出などによる視機能への影響や顔貌の変化からQOL（生活の質）の低下に悩む患者さんが多いです。一方で、活動性甲状腺眼症の治療ではステロイドパルス療法や手術療法などが必要となり、患者さんに大きな負担を伴うものでした。日本でも活動性甲状腺眼症の患者さんに対してテッペーザという全く新しい治療選択肢を提供できるようになったことは、甲状腺眼症の治療を大きく変革する重要な転機になります。」
また、発売にあたり、アムジェン希少疾患事業部長の平方利幸は次のように述べています。「活動性甲状腺眼症の患者さんのアンメット・メディカル・ニーズに応える新たな治療選択肢としてテッペーザをお届けできることを嬉しく思います。本日より本剤を確実に医療現場にお届けできるよう尽力し、必要とする患者さんが適切にアクセスできるよう環境の整備や疾患の認知向上などにも努めてまいります。今後も医療機関と連携し、テッペーザの適正使用推進に努めるとともに、約3万5千人いるとされる1日本の甲状腺眼症の患者さんのために活動を続けてまいります。」
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、日本で承認されており、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。日本では希少疾病用医薬品の指定を受けています。
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。 |
| 製造販売承認日： | 2024年9月24日 |
| 薬価： | テッペーザⓇ点滴静注用500mg 979,920円 |
| 薬価収載日： | 2024年11月20日 |
| 発売日： | 2024年11月20日 |
| 製造販売： | アムジェン株式会社 |
製剤写真
甲状腺眼症（TED）について
甲状腺眼症は、進行性かつ潜在的に視力低下の恐れがある希少で深刻な自己免疫疾患です2。その多くはバセドウ病に伴ってみられますが、眼窩線維芽細胞で発現する甲状腺刺激ホルモン（TSH）受容体とIGF-1受容体のシグナル伝達複合体を活性化する自己抗体によって引き起こされるため、甲状腺疾患とは異なる疾患です3,4。これらが一連の症状につながり、最重症例では失明など長期にわたる不可逆な損傷を引き起こす可能性があります5,6。甲状腺眼症の初期症状には、ドライアイ、異物感、充血、腫れ、過度の涙、眼瞼後退、眼球突出、目の奥の圧迫感や眼痛、複視などがあり、一般的な眼症状も含まれるため、適切な診断および治療に結びつかないケースがあります。また、多彩な眼症状は、日常生活における活動（読書、車の運転、仕事など）の制限や社会的心理面（見た目に対する懸念、気分の落ち込み・不安、公の場を避ける、など）に著しい影響を及ぼします7。
テッペーザ®（テプロツムマブ [遺伝子組換え] ）について
テッペーザⓇは、完全ヒト型モノクローナル抗体（mAb）で、IGF-1受容体の標的阻害薬です。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。米国食品医薬品庁（FDA）から優先審査、希少疾病用医薬品、ファストトラック、およびブレークスルーセラピーに指定されています。過去の治験において最も多く見られた有害事象（≥5%の発生率でプラセボより多数）は、筋痙攣や吐き気、脱毛症、下痢、疲労感、高血糖、聴覚障害、味覚障害、頭痛、乾燥肌、月経障害でした。
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。
アムジェン 希少疾患事業部について
アムジェンは、革新的な医薬品を開発し、提供することで、希少疾患を含む、最も困難な疾患と戦う多くの患者さんを支援しています。現在10,000を超える希少疾患が存在し、全世界で400万もの人々が影響を受けている一方で、希少疾患は病態が複雑であるために、しばしば適切なケアが行き届いていません。アムジェン 希少疾患事業部は「希少疾患患者へ希望を届け、生活の質を根本から変える」というミッションを核心に据え、この喫緊の課題に取り組んでいます。
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
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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この件に関するお問い合わせ先
アムジェン株式会社（東京）
コーポレート・アフェアーズ
TEL 090-6010-5792
References