Regeneron Delays Eylea HD Pre-Filled Syringe Submission Following FDA CRL

FDA发布完整回应函后，再生元推迟Eylea HD预充注射器的提交。

October 30, 2025

2025年10月30日

Regeneron Pharmaceuticals has announced a delay in its regulatory plans for the Eylea HD (aflibercept injection 8 mg) pre-filled syringe, following a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The update was included in the company’s third-quarter earnings filing..

再生元制药公司宣布，在收到美国食品药品监督管理局（FDA）的完整回复信（CRL）后，其针对Eylea HD（8毫克阿柏西普注射液）预填充注射器的监管计划将延迟。这一更新包含在公司的第三季度财报文件中。

FDA Raises Manufacturing Concerns, Not Product Safety or Efficacy

FDA提出制造方面的担忧，而非产品安全或有效性问题

According to Regeneron, the latest CRL concerns unresolved inspection findings at the manufacturing facility operated by Catalent, the contract manufacturer for the pre-filled syringe. These manufacturing-related issues remain the sole approvability concern.

根据再生元公司的说法，最新的完整回复信涉及由预充式注射器的合同制造商Catalent运营的生产设施中尚未解决的检查结果。这些与制造相关的问题仍然是唯一的可批准性担忧。

Earlier this year, in April 2025, the FDA issued the first CRL for the same supplemental Biologics License Application (sBLA), which aimed to extend Eylea HD dosing intervals to up to every 24 weeks across all approved indications. That letter also did not cite any issues related to clinical performance..

今年早些时候，即2025年4月，FDA发布了针对同一补充生物制品许可申请（sBLA）的首份完整回复函（CRL），该申请旨在将Eylea HD的给药间隔延长至所有获批适应症的每24周一次。该函件同样未提及任何与临床表现相关的问题。

Catalent Receives OAI Letter from FDA

卡特兰特收到FDA的OAI信函

In further development, Regeneron reported that Catalent has received an Official Action Indicated (OAI) letter from the FDA, which references unresolved concerns following a general site inspection conducted in July 2025. The inspection findings are not specific to Eylea HD, but they have impacted the regulatory pathway for the pre-filled syringe..

在进一步的发展中，再生元公司报告称，卡泰兰特收到了美国食品药品监督管理局（FDA）发出的“官方行动指示”（OAI）信函，其中提到2025年7月进行的一次常规场地检查后尚未解决的问题。这些检查结果并非特定于Eylea HD，但已影响到预填充注射器的监管路径。

New Submission Planned for Early 2026

计划于2026年初提交新内容

As a result of the ongoing manufacturing concerns, Regeneron stated it is now targeting a January 2026 submission for an updated BLA that will include a new pre-filled syringe manufacturing filler to address the inspection-related issues.

由于持续存在的生产问题，再生元公司表示，现在计划在 2026 年 1 月提交一份更新的 BLA，其中包括一种新的预充式注射器生产填充设备，以解决与检查相关的问题。

Additional Regulatory Submissions Under Review

其他监管提交文件正在审查中

Despite the delay, several other regulatory submissions for Eylea HD remain under review:

尽管有所延迟，Eylea HD 的其他几项监管提交仍在审查中：

• An sBLA for every-4-week dosing and for the treatment of macular edema following retinal vein occlusion (RVO) is currently being reviewed by the FDA, with a target action date in late November 2025.

• FDA目前正在审查每4周一次的剂量方案以及用于治疗视网膜静脉阻塞（RVO）后黄斑水肿的sBLA，预计在2025年11月下旬作出决定。

• Separately, Regeneron has also submitted a request to include an additional vial filler, with the FDA expected to provide a decision by late December 2025.

• 另外，再生元公司还提交了增加一个额外小瓶填充器的请求，预计美国食品药品监督管理局（FDA）将在2025年12月底前作出决定。