Amgen Seeks EMA Approval For Teprotumumab In Moderate To Severe Thyroid Eye Disease
Amgen Seeks EMA Approval For Teprotumumab In Moderate To Severe Thyroid Eye Disease
Amgen (NASDAQ:AMGN) today announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.1 If approved, teprotumumab would be the first and only medicine approved for TED in the European Union.
安進（納斯達克股票代碼：AMGN）今天宣佈，即將向歐洲藥品管理局（EMA）提交teprotumumab的上市許可申請（MAA），這是一種用於治療成人中度至重度甲狀腺眼病（TED）的全人源單克隆抗體和胰島素樣生長因子-1受體（IGF-1R）的靶向抑制劑。TED 是一種嚴重的、進行性的、虛弱的、可能威脅視力的自身免疫性疾病，可導致眼球突出（眼部隆起）、複視（複視）、眼痛、發紅和腫脹。1 如果獲得批准，teprotumumab將成爲歐盟第一種也是唯一獲准用於TED的藥物。
"We are enthusiastic to bring a much-needed medicine to the Thyroid Eye Disease community in Europe by leveraging Amgen's strong reputation and broad infrastructure in the region," said Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen. "This disease is currently managed with steroids and invasive surgeries, both of which carry their own set of risks. Having access to a non-surgical option like teprotumumab that not only treats the signs and symptoms, but also targets the underlying cause of the disease represents a major advance for patients."
安進研發執行副總裁兼首席科學官傑伊·布拉德納表示：“我們熱衷於利用安進在該地區的良好聲譽和廣泛的基礎設施，爲歐洲甲狀腺眼病界帶來急需的藥物。”“這種疾病目前是通過類固醇和侵入性手術來控制的，兩者都有其自身的風險。獲得像teprotumumab這樣的非手術方案，不僅可以治療體徵和症狀，還可以靶向疾病的根本原因，這是患者的一項重大進步。”
譯文內容由第三人軟體翻譯。