Omeros announced the United States Food and Drug Administration (FDA) agreed with the company’s proposed schedule for the rolling review of the Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
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Consistent with the agreed schedule, the company is on track to submit the BLA’s first sections, which will include the nonclinical and clinical pharmacology data, in the first half of next quarter.
Under its rolling review process, FDA can review components of a marketing application as they are submitted rather than requiring all components to be received prior to initiating review, allowing faster review of the application. The BLA for narsoplimab, because of the drug’s breakthrough therapy designation from FDA for the treatment of HSCT-TMA, is also eligible for priority review, which shortens the standard FDA review cycle by four months.