US FDA Approves Univax' WinRho

Univax has received approval from the US Food and Drug Administration to market and distribute WinRho SD (RHo (D) Immune Globulin intravenous (human)) for the suppression of Rhesus isoimmunization and the treatment of children with chronic and acute immune thrombocytopenic purpura (ITP), adults with chronic ITP, and children and adults with ITP secondary to HIV infection. The product is marketed under an exclusive license with Rh Pharmaceuticals of Canada.

WinRho SD is the only virally-inactivated RhIVIG product to be approved in the USA and can be administered intravenously or intramuscularly. The compound has Orphan Drug status for the treatment of ITP and is the only product available to specifically treat ITP secondary to HIV infection.

ITP is an autoimmune disease in which the immune system attacks and destroys platelets which are essential for blood clotting. ITP can therefore lead to uncontrolled bleeding episodes. Rho isoimmunization can occur in Rho (D) negative mothers who conceive an Rho (D) positive fetus. The Rh incompatibility can cause an immune reaction in the mothers that is potentially life-threatening to the unborn baby and to any subsequent Rho (D) positive fetus.