Baxter´s ready-to-use liquid 10% Intravenous Immunoglobulin (IVIG), has received unanimous positive opinion for marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). Once licensed, the therapy will be marketed under the name KIOVIG. It is the first IVIG that will be licensed through the EMEA's centralised approval process of the EMEA.

The CHMP has recommended that Baxter's new IVIG be indicated for replacement therapy in primary immunodeficiency disorders, myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections, children with congenital AIDS and recurrent infections, idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, Guillain Barré Syndrome, Kawasaki Syndrome and allogeneic bone marrow transplantation, states a company release.

The product offers convenience for healthcare professionals and patients: the ready-to-use preparation eliminates the need for reconstitution and its 10% concentration allows for reduced infusion time when compared to 5% concentrations. In addition, the formulation is free of added sugar, sodium and preservatives, and the packaging is latex-free. Its efficacy and tolerability has been demonstrated in multi-centre clinical trials in Europe and the United States.

“Baxter is excited about this endorsement from the CHMP, as it means that we are one step closer to bringing this new advance in the treatment of immunodeficiencies and certain autoimmune diseases to both physicians and patients in Europe," said Jim Utts, president of Baxter Europe.

Approval from the European Commission will allow Baxter to market the therapy in all 25 European Union member states, as well as Norway and Iceland. Baxter had received regulatory approval from the US FDA in May 2005, and the therapy was launched in the United States in September.

The product is a ready-to-use, sterile preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. It is processed from human plasma and contains a broad spectrum of IgG antibodies against bacterial and viral antigens.

Primary immunodeficiency disorders encompass more than 100 diseases caused by an immune system that does not function correctly. In Europe, PI affects approximately one in 500 persons, and experts estimate that another one in 500 is yet undiagnosed.