FDA提出生产担忧，延迟Unicycive肾病药物批准-动脉网

FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval

benzinga 等信源发布 2025-06-30 10:58

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The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on Monday for

美国食品药品监督管理局（FDA）周一发出了一封完整回应信（CRL）。

Unicycive Therapeutics, Inc.’s

Unicycive Therapeutics, Inc.

UNCY

联合国赛YPREME法院

New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in patients with chronic

用于治疗慢性肾病患者高磷血症的碳酸氧镧（OLC）的新药申请（NDA）

kidney disease (CKD) on dialysis

肾病（CKD）透析中

。

Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood, most commonly resulting from impaired kidney function, and can lead to complications like vascular calcification, organ damage, and increased mortality.

高磷血症是一种以血液中磷酸盐水平升高为特征的疾病，最常见原因是肾功能受损，可能导致血管钙化、器官损伤和死亡率增加等并发症。

“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said

“我们计划立即寻求与机构召开A类会议，以就确保迅速解决CRL的最佳策略达成一致，”

Shalabh Gupta

沙拉布·古普塔

, CEO of Unicycive. “With a second manufacturing, vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”.

Unicycive首席执行官表示：“随着第二家生产商的确定，该厂商已生产出OLC药物产品，我们对将这一有前景的新治疗方案带给正在管理高磷血症的CKD透析患者保持乐观。我们计划在获得FDA关于下一步行动的更多明确信息后尽快提供更新。”

After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization was cited for deficiencies following a cGMP inspection.

在提交新药申请后，作为申请审查和常规信息请求的一部分，FDA 通知 Unicycive，其主要合同开发和制造组织的第三方制造供应商在 cGMP 检查后被指出存在缺陷。

This citation is unrelated to OLC. Unicycive also notes that the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself as part of the NDA review.

此引用与OLC无关。Unicycive还指出，作为NDA审查的一部分，该机构并未强调与提交的CMC文件或OLC本身的测试相关的其他技术问题。

As part of its overall manufacturing strategy, the company had previously identified a backup third-party manufacturing vendor to build redundancy into its supply chain.

作为其整体制造战略的一部分，该公司此前已确定了一家备用的第三方制造供应商，以在其供应链中建立冗余。

Unicycive currently has an unaudited cash balance of approximately $20.7 million, with a cash runway expected to last into the second half of 2026.

目前，Unicycive未经审计的现金余额约为2070万美元，预计现金跑道将持续到2026年下半年。

Earlier in June, following an inspection, the FDA identified deficiencies at a third-party subcontractor of Unicycive’s Contract Development and Manufacturing Organization. As a result, the FDA said any label discussions with the

6月早些时候，在一次检查之后，FDA指出了Unicycive的合同开发和制造组织的第三方分包商存在缺陷。因此，FDA表示任何标签讨论都需要与

company are currently precluded

公司目前被排除在外

。

Unicycive noted the issues do not involve its Drug Substance vendor and said it has responded to all FDA information requests.

Unicycive 指出，这些问题与其药物成分供应商无关，并表示已回应了 FDA 的所有信息请求。

In June, Unicycive Therapeutics implemented a

六月，Unicycive Therapeutics 实施了

1-for-10 reverse split

1比10的反向分割

。

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