Trial Profile
Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab
Status:
Recruiting
Phase of Trial:
Clinical Phase Unknown
Latest Information Update: 08 Aug 2024
Price :
$35
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At a glance
- Drugs Narsoplimab (Primary)
- Indications Haemolytic anaemia; Thrombocytopenia; Thrombotic microangiopathy
- Focus Expanded access; Therapeutic Use
- Sponsors Omeros Corporation
- 09 Nov 2023 According to an Omeros Corporation media release, As part of our planned resubmission of our Biologics License Application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy, company submitted to FDA a formal statistical analysis plan to compare survival data from an already-identified external source. The company continue to target an FDA approval decision on our resubmitted BLA in mid-2024.
- 08 Nov 2022 According to an Omeros Corporation media release, The decision specifically suggests that the narsoplimab BLA be resubmitted along with evidence of improved survival from patients in the pivotal trial when compared to an appropriate historical control group and a comparison of the current response data from the completed pivotal trial to a threshold derived from an independent literature analysis. It also notes out that even in the absence of the independent literature analysis, strong evidence.
- 08 Nov 2022 According to an Omeros Corporation media release, FDA makes a decision about Omeros Corporation's formal dispute resolution request for narsoplimab. The decision suggests a course of action for the re-submission of the BLA based on survival data from the completed pivotal trial versus a historical control group. The request was denied.