Univax Biologics Inc. said Thursday that it has filed a productlicense application (PLA) with the FDA to market WinRho SD, ahyperimmune intravenous human polyclonal antibody, forsevere blood disorders.
The Rockville, Md., company (NASDAQ:UNVX) said primaryindications include treatment of idiopathic thrombocytopenicpupura (ITP) and prevention of Rh isoimmunization innewborns. Characterized by abnormally low platelet levels andrisks of excessive bleeding and bruising, ITP affects 137,000Americans annually, including 11 percent of people infectedwith HIV. Of the non-HIV cases, about 4,000 are children.
In Phase III trials of 300 children and adults with ITP andAIDS-related ITP, WinRho SD increased platelet counts abovethe treatment threshold in all subgroups.
The treatment is produced by stimulating plasma donors withRh-positive red blood cells in a process similar to that used toprepare antibody products for protection against tetanus,rabies and hepatitis B.
Univax licensed marketing rights for WinRho SD from theCanadian company Rh Pharmaceuticals in November 1992.WinRho SD is licensed in Canada for prevention of Rhisoimmunization. Univax has already applied for orphan drugdesignation for its use in ITP.
This is the first of its five products under development to reachPLA review.
Univax's stock closed at $8.25 a share on Thursday, off 50cents.
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