Omeros Corporation (Nasdaq: OMER) has shared an update on its ongoing efforts to resubmit the biologics license application (BLA) for narsoplimab, its first-in-class antibody targeting MASP-2, a key enzyme in the lectin pathway of complement activation. Narsoplimab is being developed for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
During its recent quarterly earnings report and call, Omeros noted it was awaiting feedback from the U.S. Food and Drug Administration (FDA) on a revised statistical analysis plan (SAP) for the BLA. The company has now received the FDA’s response and confirmed there are no other pending pre-submission information requests or known obstacles to resubmitting the application.
Once data preparation is completed, an independent expert statistical group will conduct primary endpoint and other analyses based on the revised SAP. If the analytical results meet the necessary requirements, Omeros plans to finalize and submit the BLA promptly.
As previously reported, the FDA provided minor feedback during a September 2024 meeting regarding Omeros’ proposed BLA resubmission. The feedback focused on additional sensitivity analyses for the primary efficacy endpoint. Omeros revised and resubmitted the SAP to address these comments. The FDA has now provided further recommendations, which Omeros has deemed acceptable.
The independent statistical group will incorporate the FDA’s recommendations into the final SAP, update and validate the relevant statistical programs, and perform the required efficacy analyses. Following the validation of the results, Omeros will publicly share the findings from the primary analysis along with additional analyses as they are completed.
Omeros remains committed to advancing narsoplimab as a potential treatment for TA-TMA and anticipates a swift BLA resubmission once all requirements are met.
