Kiovig, Baxter's new ivig Product receives unanimous postive opinion in Europe as replacement therapy for immunodeficiencies and for immunomodulation in immune-mediated deseases
Zurich (ots) - Baxter Healthcare S.A. announced today that Baxter"s ready-to-use liquid 10% Intravenous Immunoglobulin (IVIG), has received unanimous positive opinion for marketing authorization 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 centralized 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 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 Barré Syndrome, Kawasaki Syndrome and allogeneic bone marrow transplantation.
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. It's efficacy, and tolerability has been demonstrated in multi-center 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
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 U.S. Food and Drug Administration (FDA) in May 2005, and the therapy was launched in the United States in September. A submission for approval has also been made to Swissmedic, the Swiss Agency for Therapeutic Products in February 2005 as well as to Health Canada's Drug Directorate in December 2004.
ABOUT Baxter's liquid 10% IVIG
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. 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. To further support the margin of safety, three validated, independent and effective virus inactivation/removal steps have been integrated into processing and formulation. ABOUT PRIMARY IMMUNODEFICIENCY DISORDERS
Primary immunodeficiency disorders encompass more than 100 diseases caused by an immune system that does not function correctly. In Europe, PI affect approximately one in 500 persons, and experts estimate that another one in 500 are yet undiagnosed. For the EU, this is equivalent to 1.5 million affected individuals, 50 percent of whom are undiagnosed. IVIG therapy can restore IgG levels to normal or near normal, helping the immune system function properly and prevent infections or combat them when they occur.
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. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
(Baxter and KIOVIG are trademarks of Baxter International Inc.)
This release includes forward-looking statements concerning further approvals of and the availability of KIOVIG. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: completion of final regulatory approvals; development issues that may arise in bringing the therapy to market; and other risks identified in the company's most recent filing with the Securities and Exchange Commission on Form 10-Q. The company does not undertake to update its forward-looking statements.
ots Originaltext: Baxter Healthcare SA
Dr. Ulrike Engels-Lange, Baxter
Baxter Healthcare SA