Re: Farmas USA
OMER
Omeros Requests Fast Track Designation for OMS721 for the Treatment of IgA Nephropathy
FDA already has granted fast track designation for OMS721 in patients with atypical hemolytic uremic syndrome (aHUS) and orphan designation for OMS721 in patients with thrombotic microangiopathies (TMAs), including aHUS and hematopoietic stem cell-associated TMAs (HSCT-TMAs).
In addition to positive Phase 2 data in IgA nephropathy and membranous nephropathy, Omeros has reported positive data from Phase 2 clinical trials in both aHUS and HSCT-TMAs. Following guidance from FDA and from the European Medicines Agency, Omeros plans to open enrollment for its single Phase 3 trial in patients with aHUS later this year. Based on discussions with the FDA, the company is also pursuing breakthrough therapy designation for OMS721 in IgA nephropathy and in HSCT-TMAs, neither of which has any approved treatment
http://finance.yahoo.com/news/omeros-requests-fast-track-designation-110000967.html
«Después de nada, o después de todo/ supe que todo no era más que nada.»