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Baxter receives EU authorization for Kiovig to treat immunodeficiencies
By Lisa Kerner
Erie, Pa., Jan. 25 - Baxter Healthcare SA said the European Medicines Agency has issued a Marketing Authorization for Kiovig (immune globulin intravenous (human)), Baxter's ready-to-use liquid 10% intravenous immunoglobulin.
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.
Kiovig is indicated in the European Union for replacement therapy in Primary Immunodeficiency Disorders (PID), which encompass more than 100 diseases caused by an immune system that does not function correctly, according to a company news release.
Kiovig's efficacy and tolerability have been demonstrated in multi-center clinical trials in Europe and the United States, said the company.
"The launch of Kiovig is the latest step in Baxter's efforts toward advancing the science of IVIG [intravenous immunoglobulin]," Jim Utts, president of Baxter Europe, said in the release.
Baxter said it received regulatory approval for Kiovig from the Food and Drug Administration in May 2005. The therapy was launched in the United States in September.
The product was approved in Switzerland in November 2005. A submission for approval was also made to Health Canada's Drug Directorate in December 2004.
Kiovig is a ready-to-use, sterile 10% preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies processed from human plasma, said the company.
Baxter Healthcare SA, based in Zurich, Switzerland, is the principal European operating subsidiary of Baxter International Inc., a medical devices, pharmaceuticals and biotechnology company.
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