Omeros Corporation Receives Decision from FDA on Formal Dispute Resolution Request for Narsoplimab
Omeros Corporation (Nasdaq: OMER) today announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has reached a decision on the company’s formal dispute resolution request appealing the issuance by FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) and the Division of Nonmalignant Hematology (the review division) of a complete response letter (CRL) concerning the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)
SEATTLE--(BUSINESS WIRE)--Nov 8, 2022--
Omeros Corporation (Nasdaq: OMER) today announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has reached a decision on the company’s formal dispute resolution request appealing the issuance by FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) and the Division of Nonmalignant Hematology (the review division) of a complete response letter (CRL) concerning the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
In its formal dispute resolution request submitted to the Agency in June 2022, Omeros requested OND to direct the review division to accept resubmission of the existing BLA and to commence labeling discussions with the company immediately thereafter. Although that request was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus an historical control group. Specifically, the decision proposes the resubmission of the narsoplimab BLA including a comparison of the existing response data from the completed pivotal trial to a threshold derived from an independent literature analysis and evidence of increased survival from patients in the pivotal trial compared to an appropriate historical control group. It also notes that persuasive evidence of superior survival versus a well-matched historical control group could be sufficient even in the absence of the independent literature analysis. The specific approach to resubmission and its details would be determined through discussion with the review division.
Omeros is currently working through the details of the decision and potential next steps with its team of regulatory and legal advisors and will discuss this development further on its previously announced earnings call scheduled for tomorrow, November 9, 2022.
