Omeros Corporation issued the following announcement on Sep. 11.
Omeros Corporation (Nasdaq: OMER) announced that 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).
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.
Omeros referenced FDA’s agreement with the company’s proposed schedule for its rolling BLA during a webcast presentation given yesterday by Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer, at the H.C. Wainwright 21st Annual Global Investment Conference. Omeros has received informational requests from investors regarding this agreement. In addition to the information contained in this release, an archived recording of the webcast presentation can be accessed on the Investors & News/Events section of Omeros’ website at www.omeros.com.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. The company’s drug product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
Original source can be found here.
