Therapy Areas: Central Nervous System
US FDA Extends Review Period for Narsoplimab in HSCT-TMA
20 May 2021 - - The US Food and Drug Administration will require additional time to review the Biologics License Application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), US-based biopharmaceutical company Omeros Corp. (NASDAQ: OMER) said.

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.