OSAKA, Japan and CAMBRIDGE, Massachusetts, September 27, 2023 – Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous (IV).1 Entyvio SC is expected to be available in the U.S.

日本大阪和马萨诸塞州剑桥，9月27日，2023年-今天武田宣布，美国食品和药物管理局（FDA）已批准Entyvio®（vedolizumab）皮下（SC）给药，用于Entyvio静脉诱导治疗后中度至重度活动性溃疡性结肠炎（UC）成人的维持治疗（IV）.1 Entyvio SC预计将在美国上市。

as a single-dose pre-filled pen (Entyvio Pen) by the end of October. Additionally, a Biologics License Application for an investigational SC administration of Entyvio for the treatment of adults with moderately to severely active Crohn’s disease is currently under review by the FDA.“With the FDA approval of subcutaneous Entyvio, patients and physicians who want Entyvio’s clinical profile along with flexibility of administration now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis,” said Brandon Monk, senior vice president, head, U.S.

作为单剂量预填笔（Entyvio笔），截至10月底。此外，FDA目前正在审查Entyvio研究性SC管理用于治疗中度至重度活动性克罗恩病成人的生物制剂许可申请。美国头部高级副总裁Brandon Monk说：“在FDA批准皮下Entyvio的情况下，希望Entyvio的临床表现以及灵活性的患者和医生现在可以选择两种维持治疗方法来治疗中度至重度溃疡性结肠炎的成人。”。

Gastroenterology Business Unit, Takeda. “Takeda is committed to meeting the varied medical needs, circumstances and personal preferences of people living with UC as they progress in their lifelong journey with the disease. Entyvio is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”The approval of this new route of administration for Entyvio is based on the VISIBLE 1 study (SC UC Trial).

武田消化内科业务部门。“武田致力于满足溃疡性结肠炎患者一生中的各种医疗需求，环境和个人喜好，Entyvio是唯一获得FDA批准的用于溃疡性结肠炎维持治疗的生物制剂，可选择静脉内或皮下给药。“Entyvio的这一新的管理途径的批准基于VISIBLE 1研究（SC UC试验）。

VISIBLE 1 was a Phase 3, randomized, double-blind, placebo-controlled trial that assessed the safety and efficacy of an SC formulation of Entyvio as maintenance therapy in adult patients with moderately to severely active UC who achieved clinical response* at Week 6 following two doses of open-label vedolizu.

可见1是一项3期，随机，双盲，安慰剂对照试验，评估Entyvio SC制剂作为维持治疗对中度至重度活动性UC成年患者的安全性和有效性，这些患者在第6周达到临床反应*两剂开放标签vedolizu。