Baxter Healthcare receives EMEA approval for Kiovig

Baxter Healthcare’s ready-to-use liquid ten per cent Intravenous Immunoglobulin (IVIG), has received marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

The first IVIG to be licensed through the EMEA’s centralised approval process, the drug will be known as Kiovig when it hits the market.

The CHMP has recommended that Baxter’s new IVIG be indicated for replacement therapy in primary immunodeficiency disorders, myeloma or Chronic Lymphocytic Leukemia (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 Barre Syndrome, Kawasaki Syndrome and allogeneic bone marrow transplantation.

The ready-to-use preparation eliminates the need for reconstitution and its ten per cent concentration allows for reduced infusion time when compared to five per cent concentrations.

“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.

A CHMP recommendation serves as the basis for European Commission approval, which typically follows in approximately 90 days. 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 Food and Drug Administration (FDA) in May 2005, and the therapy was launched in the United States in September.

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