The new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021.
As part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request. FDA has classified the response as a major amendment, which requires additional time to review.
The first drug submitted to FDA for approval in HSCT-TMA, narsoplimab has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.
The BLA for narsoplimab in HSCT-TMA was accepted for filing in January 2021 under FDA's Priority Review program.
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders.
Its commercial product Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery.
Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.
Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19.
OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial.
Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds.
One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors.
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