28 October 2019 - Rolling submission of the remaining BLA sections continues on track for scheduled completion 1H 2020.

Omeros Corporation has submitted the first sections of the rolling submission of its Biologics License Application (BLA) to the U.S. 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.

Included 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 clinical data collection, dataset compilation and data analysis are complete, the clinical parts of the BLA are scheduled for submission to be followed by the quality (i.e., chemistry, manufacturing and controls) section. Serial submission of the clinical and quality sections remains on track for scheduled completion in the first half of next year. Omeros anticipates that FDA will grant the BLA submission for narsoplimab a priority review which, under the Prescription Drug User Fee Act, further shortens FDA’s overall review time.

Read Omeros Corporation press release