Healthcare Industry News: GAMMAGARD
News Release - January 25, 2006
Baxter Receives Marketing Authorization From the European Commission for KIOVIG to Treat ImmunodeficienciesZURICH, Switzerland, Jan. 25 (HSMN NewsFeed) -- Baxter Healthcare S.A. announced today that the European Medicines Agency (EMEA) has issued a Marketing Authorization for KIOVIG(TM) [Immune Globulin Intravenous (Human)], Baxter's ready-to-use liquid 10% Intravenous Immunoglobulin (IVIG).
KIOVIG is indicated in the European Union for replacement therapy in Primary Immunodeficiency Disorders (PID), Myeloma or Chronic Lymphocytic Leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections, children with congenital AIDS and recurrent infections, Kawasaki Syndrome, allogeneic bone marrow transplantation, Guillain Barre 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-center 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," said Jim Utts, president of Baxter Europe. "We are excited to offer this new liquid IVIG to help meet the needs of physicians, healthcare professionals and patients."
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 U.S. 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.
The product 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. To further support the margin of safety, three validated, independent and effective virus inactivation/removal steps have been integrated into processing and formulation (solvent/detergent (S/D) treatment, nanometer filtration and low pH incubation at elevated temperature).
About Primary Immunodeficiency Disorders
Primary Immunodeficiency Disorders (PID) encompass more than 100 diseases caused by an immune system that does not function correctly. In Europe, PID affects approximately one in 500 people, and experts estimate that another one in 500 is 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.
About Autoimmune Disorders
Autoimmune disorders encompass a broad spectrum of human illnesses. Autoimmune diseases are defined as diseases in which the progression from benign autoimmunity to pathogenic autoimmunity occurs. In such cases the immune system mistakenly identifies a person's own tissues (e.g. nerve cells) as foreign and attacks and destroys them. Examples of autoimmune diseases are idiopathic thrombocytopenic purpura (ITP) and Guillain Barre Syndrome (GBS). IVIG therapy can help neutralize auto-antibodies and also help modulate B-cell response, which may lead to stabilization of the patient.
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.
Important Safety Information for the United States
KIOVIG is marketed as GAMMAGARD LIQUID(TM) [Immune Globulin Intravenous (Human)], in the United States.
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction. Such patients should only receive intravenous immune globulin with utmost caution and in a setting where supportive care is available for treating life-threatening reactions.
IVIG products have been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIG products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD LIQUID does not contain sucrose.
GAMMAGARD LIQUID is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.
The potential risks and benefits of IVIG should be weighed against those of alternative therapies for all patients for whom IVIG administration is being considered.
Please visit http://www.GAMMAGARDliquid.com for full U.S. prescribing information.
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