Univax reaches first product milestone

Univax Biologics Inc. (UNVX) filed its first product license application with the FDA, to market WinRho SD for treatment of idiopathic thrombocytopenic purpura (ITP), a blood disorder characterized by abnormally low platelet levels. The primary indications for WinRho SD include the treatment of ITP and ITP secondary to HIV infection as well as prevention of Rh isoimmunization in newborns.

UNVX licensed U.S. marketing rights for WinRho SD, a hyperimmune intravenous human polyclonal antibody, from Rh Pharmaceuticals of Canada, where it is approved for prevention of Rh isoimmunization. UNVX has applied for orphan drug designation for the use of WinRho SD in the treatment of ITP...