Univax Biologics Inc. announced Monday that FDA has grantedthe company's polyclonal antibody, WinRho, orphan drug statusfor treatment of the autoimmune disease idiopathicthrombocytopenic purpura (ITP).
The blood disorder is characterized by a patient's antibodiesattacking circulating platelets necessary for blood clotting. ITPafflicts approximately 5 percent to 10 percent of people withHIV infection and can result in hemorrhage, excessive bleedingand purplish bruising.
Univax said approximately 97,000 people in the U.S. have ITP,of which about 50,000 have the disorder secondary to HIV.
Univax (NASDAQ:UNVX) of Rockville, Md., filed a productlicense application for WinRho in June. In a Phase III trial of210 patients reported last December, the antibody increasedplatelet count in 60 to 80 percent of patients.
In 1992, the company licensed exclusive rights to market thehyperimmune intravenous human polyclonal antibody in theU.S. from Rh Pharmaceuticals of Canada. Rh Pharmaceuticalsmarkets the drug in Canada for prevention of RHisoimmunization in newborns. -- Brenda Sandburg
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