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Omeros’ Narsoplimab Receives Positive Opinion from European Medicines Agency for Pediatric Investigation Plan Required for MAA Submission
– Includes Deferral for PIP Completion Until After Approval of Marketing Authorization Application – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq:
About this update from Omeros Corporation
[{"type":"text","content":"\n– Includes Deferral for PIP Completion Until After Approval of Marketing Authorization Application –\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has issued a positive opinion for the company’s pediatric investigation plan (PIP) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab, also referred to as OMS721, is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2).\n\n\nAcceptance of the PIP paves the way for submission under the European Commission’s centralized procedure of a Marketing Authorization Application (MAA) for narsoplimab in the treatment of HSCT-TMA. A PIP outlining a development program for the investigational product in the pediatric population must be agreed with PDCO as a prerequisite to EMA’s acceptance of an MAA. The narsoplimab PIP provides a study plan to evaluate the safety and effectiveness of the drug for HSCT-TMA in patients from 1 month through 17 years of age. Omeros received a deferral for completion of its pediatric plan until after EMA approval of the narsoplimab MAA. With successful completion of the PIP, narsoplimab would be eligible for up to an additional two years of marketing exclusivity.\n\n\nIn addition to its planned MAA, Omeros recently initiated the rolling submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab in HSCT-TMA. Omeros will work with FDA to allow the same study plan outlined in the PIP to form the basis for a Written Request from FDA to extend marketing exclusivity for narsoplimab under the Best Pharmaceuticals for Children Act. Successful completion of the pediatric plan would add up to six months to the longest applicable U.S. non-patent exclusivity period.\n\n\n“We appreciate EMA’s guidance through the successful PIP review process for narsoplimab in stem cell transplant-associated TMA,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We believe that the clinical response to narsoplimab seen across our pivotal clinical trial and compassionate use bodes well for the additional young patients who will receive the drug in our PIP study....