The US FDA has approved the liquid formulation of Cangene Corporation WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)]. WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura (ITP), Baxter Healthcare Corporation and Cangene Corporation jointly announced here.

WinRho SDF Liquid provides an alternative to the lyophilized (freeze-dried) therapeutic, which eliminates the need for reconstitution prior to administration. Last month, Baxter assumed from Cangene exclusive rights to market and distribute WinRho SDF in the US, a lyophilized version of which has been available in the US since 1995.

Baxter currently markets lyophilized WinRho SDF for Cangene in the United States and the United Kingdom and intends to launch this therapy in 10 other European countries.

WinRho SDF is derived from human plasma and administered intravenously for the treatment of ITP, which is an autoimmune bleeding disorder caused by an abnormally low level of platelets. In ITP, the immune system produces antibodies against platelets causing their premature destruction. Platelets are components of the blood that are necessary for blood to clot properly. Individuals who suffer from ITP may have symptoms such as bruising on skin and gums, nosebleeds, or mucosal bleeding. The most serious risk in patients who develop ITP is intracranial haemorrhage (bleeding into the brain).