Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 clinical trial. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application (BLA) pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. The first drug candidate submitted to FDA for approval in TA-TMA, narsoplimab has Breakthrough Therapy and Orphan-Drug designations in this disorder as well as in IgA nephropathy. We look forward to working with the Agency to obtain approval for narsoplimab as soon as possible.” “There currently is no approved treatment for TA-TMA, and transplant physicians and their patients need one. Demopulos, M.D., chairman and chief executive officer of Omeros. “While this decision does not allow us to begin labeling discussions now, it does provide paths forward based on collecting historical data with or without an independent literature review,” said Gregory A. 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. The specific approach to resubmission and its details would be determined through discussion with the review division. 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. 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. 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. 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. 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). Omeros Corporation (Nasdaq: OMER) today announced that the Office of New Drugs (OND) of the U.S. Decision Proposes a Path Forward Based on Historical Survival Data. Decision Denies Omeros’ Appeal Requesting Immediate Labeling Discussions.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |