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Omeros Corporation Initiates BLA Submission for Narsoplimab for the Treatment of HSCT-TMA
– Rolling Submission of the Remaining BLA Sections Continues On Track for Scheduled Completion 1H 2020 – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation
About this update from Omeros Corporation
[{"type":"text","content":"\n– Rolling Submission of the Remaining BLA Sections Continues On Track for Scheduled Completion 1H 2020 –\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) has submitted the first sections of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a far-too-often deadly complication of stem-cell transplantation.\n\n\nNarsoplimab, also known as “OMS721,” is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). There currently is no approved product for the treatment or prevention of HSCT-TMA, and narsoplimab is the only drug in development for the treatment of HSCT-TMA with FDA’s breakthrough therapy designation. Narsoplimab also has been granted FDA’s orphan drug designation for this indication.\n\n\nLast month, Omeros announced that FDA had agreed with the company’s proposed schedule for the rolling review of its BLA for narsoplimab in the treatment of HSCT-TMA. Rolling submission enables Omeros to submit sections of the BLA as they are completed, which can accelerate the time to approval by allowing FDA to review the sections as they are submitted rather than waiting to begin its review until the entire BLA has been submitted. Because narsoplimab has orphan drug designation for HSCT-TMA, FDA has waived the approximately $3 million prescription drug user fee that would normally be due when BLA submission is initiated.\n\n\n“This is an important milestone for Omeros, our shareholders and, most importantly, those patients who will undergo stem-cell transplantation,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We look forward to continuing to work closely with FDA and European regulators to make narsoplimab commercially available as soon as possible to patients who need it. Until that time, we remain committed to making the drug readily accessible to stem cell-transplant TMA patients and their physicians through our expanding compassionate-use program.”\n\n\nIncluded in today’s announced submission are all of the nonclinical (i.e., pharmacology, pharmacokinetics and toxicology) data, study reports, overview and summaries of the BLA. Once all clin...