Omeros Corporation announced that the FDA has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

奥默罗斯公司宣布，FDA已接受重新提交的用于治疗造血干细胞移植相关血栓性微血管病（TA-TMA）的Narsoplimab生物制品许可申请（BLA）进行审查。

The resubmission was classified as a Class 2 resubmission and pursuant to the Prescription Drug User Fee Act (PDUFA) has been assigned a target action date for the FDA decision in late September 2025.

重新提交被归类为第二类重新提交，并且根据《处方药使用者付费法案》（PDUFA），FDA的决定目标行动日期被定于2025年9月下旬。

The BLA resubmission includes the primary set of analyses comparing overall survival for narsoplimab-treated patients to overall survival for an external control group of TA-TMA patients. Results of those analyses showed clinically meaningful and statistically significant improvements in survival associated with narsoplimab treatment.

BLA重新提交的内容包括将接受narsoplimab治疗的患者的整体生存率与外部TA-TMA患者对照组的整体生存率进行比较的主要分析集。这些分析的结果显示，与narsoplimab治疗相关的生存率具有临床意义且统计学上显著的改善。

Also included in the resubmission are data describing survival in Omeros’ expanded access program in which adult and pediatric TA-TMA patients were treated with narsoplimab. Since resubmission of the BLA in late March, Omeros has received and is responding to information requests from FDA and expects an interactive review by FDA..

重新提交的内容还包括描述Omeros扩大使用计划中生存率的数据，该计划中的成年和儿童TA-TMA患者接受了narsoplimab的治疗。自3月底重新提交生物制品许可申请（BLA）以来，Omeros已收到FDA的信息请求并正在回应，预计FDA将进行互动审查。

Omeros is also preparing a marketing authorization application (MAA) for narsoplimab in TA-TMA, which is targeted for submission to the European Medicines Agency later this quarter.

奥默罗斯公司还正在准备针对TA-TMA适应症的narsoplimab的上市许可申请（MAA），计划在本季度晚些时候提交给欧洲药品管理局。

Condition:

条件：

Thrombotic Microangiopathies /HSCT- TMA

血栓性微血管病 /HSCT-TMA

Type:

类型：

drug

药物