TOKYO, Nov.19, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15, 2024, regarding the supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

东京，2024年11月19日–Astellas Pharma Inc.（东京证交所：4503，总裁兼首席执行官：冈村直树，“Astellas”）今天宣布，美国食品和药物管理局（FDA）于2024年11月15日发布了一份完整的回复信（CRL），内容涉及IZERVAY™的补充新药申请（sNDA）（avacincaptad pegol玻璃体内溶液），用于治疗继发于年龄相关性黄斑变性（AMD）的地理萎缩（GA）。

The sNDA sought to include positive two-year data in the U.S. Prescribing Information for IZERVAY based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly (EM) and every other month (EOM) dosing through year 2.The FDA stated the agency cannot approve the sNDA in its present form by the Prescription Drug User Fee Act (PDUFA) action date of November 19, 2024.

sNDA试图根据GATHER2第三阶段临床试验的结果，在美国IZERVAY处方信息中纳入两年的积极数据，该试验评估了第二年每月（EM）和每隔一个月（EOM）给药的有效性和安全性。FDA表示，该机构无法在2024年11月19日的《处方药用户费用法案》（PDUFA）行动日期之前批准目前形式的sNDA。

The FDA comments outlined in the CRL are unrelated to the safety and benefit/risk of the use of IZERVAY; rather, the comments focus on a statistical matter related to labelling language proposed by Astellas.Astellas is seeking further clarification from the FDA and looks forward to working with the agency to quickly address the agency’s feedback.Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma“Astellas stands by the clinical profile of IZERVAY, the only FDA-approved GA treatment that consistently demonstrated statistically significant slowing of GA across two pivotal Phase 3 studies.

CRL中概述的FDA评论与使用IZERVAY的安全性和益处/风险无关；相反，这些评论侧重于与Astellas提出的标签语言有关的统计问题。Astellas正在寻求FDA的进一步澄清，并期待着与FDA合作，迅速解决FDA的反馈。Astellas Pharma“Astellas”生物制药和眼科发展高级副总裁Marci English支持IZERVAY的临床概况，IZERVAY是FDA批准的唯一一种GA治疗方法，在两项关键的3期研究中始终显示GA的统计学显着减慢。

While this is a disappointment for patients and physicians who rely on IZERVAY for the management of a chronic, progressive disease that can lead to irreversible vision loss, Astellas is unwavering in our commitment to the ophthalmology space and will continue to work with the FDA to advance solutions for those suffer.

虽然这对依赖IZERVAY治疗可能导致不可逆转视力丧失的慢性进行性疾病的患者和医生来说是一个失望，但Astellas坚定不移地致力于眼科领域，并将继续与FDA合作，为这些患者提供解决方案。