The European Medicines Agency (EMEA) has issued a marketing authorisation for Baxter Healthcare's KIOVIG [Immune Globulin Intravenous (Human)], the company's ready-to-use liquid 10% intravenous immunoglobulin (IVIG).

According to a Baxter release, KIOVIG is indicated in the European Union for replacement therapy in primary immunodeficiency disorders (PID), myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections, children with congenital AIDS and recurrent infections, Kawasaki Syndrome, allogeneic bone marrow transplantation, Guillain Barré Syndrome, and Idiopathic Thrombocytopenic Purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

The product offers fast and effective treatment and enhanced convenience. Its efficacy and tolerability have been demonstrated in multi-centre clinical trials in Europe and the United States. The manufacturing process also incorporates three dedicated viral reduction steps. The ready-to-use preparation eliminates the need for reconstitution and its 10% concentration allows for reduced infusion volume when compared to 5% concentrations. In addition, it is the first and only 10% IVIG solution with the following combination of features: no added sugars, no added sodium, no added preservatives, latex-free packaging and an option to store the product at room temperature for up to nine months.

"The launch of KIOVIG is the latest step in Baxter's efforts toward advancing the science of IVIG. We are excited to offer this new liquid IVIG to help meet the needs of physicians, healthcare professionals and patients," said Jim Utts, president of Baxter Europe.

KIOVIG received a unanimous positive opinion recommendation from the Committee for Medicinal Products for Human Use (CHMP) in November of 2005, which served as the basis for approval by the European Commission. 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 received regulatory approval from the US Food and Drug Administration (FDA) in May of 2005, and the therapy was launched in the United States in September. In Switzerland, the product was approved in November of 2005. A submission for approval was also made to Health Canada's Drug Directorate in December of 2004.

KIOVIG is a ready-to-use, sterile 10% 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 infectious agents. Assuring state of the art quality standards for the manufacture begins with the donor selection process and continues throughout plasma collection, which only occurs at licensed plasma collection facilities.

Baxter Healthcare S.A. is the principal European operating subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma.