食品药品监管局批准Enspryng治疗甲状腺眼病 成首款可居家皮下注射的该病疗法

食品药品监管局（FDA）10月16日批准Enspryng（通用名satralizumab）用于治疗成人甲状腺眼病（TED）。罗氏公司10月16日在Basel宣布了这一批准。该药由此成为首款、也是目前唯一一款可居家皮下注射的甲状腺眼病疗法，也是首个获批用于该病的白细胞介素-6受体（IL-6R）抑制剂；经医护人员培训后，患者本人或护理者可自行注射，维持期每四周一次。甲状腺眼病是一种罕见的自身免疫性疾病，美国每10万人中约有155人患病，未经治疗可导致面部变形与威胁视力的并发症。此次批准基于三期临床试验SatraGO-1与SatraGO-2的数据，两项试验共纳入258名患者。在SatraGO-2中，接受Enspryng治疗的活动期患者有52.9%达到眼球突出应答，安慰剂组为23.4%；复视减轻的比例为60.7%，安慰剂组为25.8%。SatraGO-1未达到其第24周的预设主要终点。两项试验未发现新的安全信号，其安全性与该药已知的特征一致。Enspryng此前已于2020年获批用于视神经脊髓炎谱系障碍（NMOSD），此次为其第二个适应症；FDA此前已对该补充申请授予优先审评。罗氏首席医学官 Levi Garraway 表示，此次批准为长期以来治疗选择有限的甲状腺眼病患者提供了一个重要的新选择。临床试验研究者、宾夕法尼亚大学 Scheie 眼科研究所副教授 César A. Briceño 表示，可居家给药的皮下疗法能为患者与医生提供更大的灵活性，并减轻输注治疗的后勤负担。（资料来源：罗氏、Genentech 2026年10月16日公告及FDA批准信息）

FDA Approves Enspryng for Thyroid Eye Disease, the First At-Home Subcutaneous Treatment for the Condition

The Food and Drug Administration (FDA) on October 16 approved Enspryng (satralizumab) for the treatment of adults with thyroid eye disease (TED), Roche announced the same day in Basel. The approval makes Enspryng the first and only at-home subcutaneous treatment option for the condition and the first interleukin-6 receptor (IL-6R) inhibitor approved for the indication; after training from a health care provider, patients or caregivers can administer the injection themselves, every four weeks during the maintenance phase. Thyroid eye disease is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the United States and can lead to facial disfigurement and vision-threatening complications if left untreated. The approval rests on the Phase III SatraGO-1 and SatraGO-2 studies, which enrolled 258 patients in total. In SatraGO-2, 52.9 percent of patients with active disease treated with Enspryng achieved a proptosis response, compared with 23.4 percent on placebo, and diplopia was reduced in 60.7 percent versus 25.8 percent. SatraGO-1 did not meet its pre-specified primary endpoint at week 24. No new safety signals were identified, and the safety profile was consistent with the drug's known profile. Enspryng was first approved in 2020 for neuromyelitis optica spectrum disorder (NMOSD), making TED its second indication; the FDA had granted priority review to the supplemental application. Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said the approval provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices. César A. Briceño, a clinical trial investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute of the University of Pennsylvania, said an effective subcutaneous option could provide greater flexibility for patients and physicians while reducing the logistical burden of infusion-based therapies. (Source: Roche and Genentech announcement, October 16, 2026, and FDA approval information)

来源：GSM·美国（原文链接）

图片来源：图：食品药品监管局（FDA）官方照片，公共领域（FDA总部 White Oak 园区入口）

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