FDA approves Gammagard Liquid 10% for patients with primary immunodeficiency disorders

Drug News -- May 2, 2005

FDA approves Gammagard Liquid 10% for patients with primary immunodeficiency disorders

DEERFIELD, ILL., May 2, 2005 -- Baxter Healthcare announced that the FDA has approved Gammagard Liquid [Immune Globulin Intravenous (Human)] (IGIV) 10% Solution for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

Primary immunodeficiency is a group of genetic disorders in which the immune system fails to produce adequate amounts of antibodies, thereby predisposing individuals to increased risk of infection. The company plans to launch the plasma-based therapy in the fourth quarter of this year.
 
Gammagard Liquid 10% offers improved convenience for healthcare professionals and patients. The ready-to-use, sterile preparation of Gammagard Liquid 10% eliminates the need for reconstitution. In addition, its high concentration, compared to 5% concentrations, allows for a reduction in the length of infusion, reducing the infusion volume and saving time for both patients and healthcare professionals.

The safety of Gammagard Liquid 10% has been demonstrated in a wide spectrum of patients with primary immunodeficiency disorders. Baxter produces the therapy using a three-step viral reduction process, a unique combination used to help ensure viral safety. Gammagard Liquid 10% is free of added sugar, sodium, and preservatives. In addition, the packaging is latex-free.

"The approval of Gammagard Liquid 10% is an exciting milestone in the treatment of primary immunodeficiency disorders, allowing for increased convenience to help patients best manage their health," said Fred Modell, president and co-founder, Jeffrey Modell Foundation.

"As researchers continue to increase their knowledge and understanding of primary immunodeficiency disorders, the approval of this next generation IGIV will truly benefit patients with these disorders," said Marcia Boyle, chairman and chief executive officer, Immune Deficiency Foundation. "The Immune Deficiency Foundation applauds Baxter for its commitment to providing therapies for our community."

The approval was based on a Phase III, multicenter study of 61 patients between the ages of 6 and 72 years who were treated with 300 to 600 mg/kg every 21 to 28 days for 12 months. In this study, no validated acute serious bacterial infections occurred in any of the treated subjects.

"During the clinical trial, we found that Gammagard Liquid 10% was safe and effective in the treatment of patients with primary immunodeficiency disorders," said Joseph Church, M.D., Professor of Clinical Pediatrics, Keck School of Medicine at the University of Southern California, Head of the Division of Clinical Immunology and Allergy at Childrens Hospital Los Angeles and a lead investigator in the clinical trial. "In addition, the production of Gammagard Liquid 10% incorporates a three-step viral reduction process that may improve viral safety."

Baxter intends to launch Gammagard Liquid 10% in five vial sizes (1g, 2.5g, 5g, 10g and 20g). The various vial sizes will allow for tailored dosing and help reduce waste. Healthcare institutions will also benefit from the therapy's recommended storage conditions. Gammagard Liquid 10% can be stored for up to nine months at room temperature, or for up to 36 months if kept under refrigeration.

"We developed this next generation IGIV therapy in direct response to the needs of patients and healthcare professionals," said Joy Amundson, president of Baxter's BioScience business. "We are proud to add this important innovation to Baxter's 50-year history and commitment to safe and effective plasma therapies."

About Gammagard Liquid 10%

Gammagard Liquid 10% is a ready-to-use, sterile preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. Gammagard Liquid 10% is processed from human plasma and contains a broad spectrum of IgG antibodies against bacterial and viral agents. The quality of Gammagard Liquid 10% begins with the donor selection process and continues throughout plasma collection, which only occurs at FDA-approved blood establishments, and plasma preparation. To further support the margin of safety, three validated, independent and effective virus inactivation/removal steps have been integrated into processing and formulation, namely solvent/detergent (S/D) treatment, 35 nanometer filtration, and a low pH incubation at elevated temperature.

Baxter will continue to supply its current Gammagard S/D to those patients who require a low Immunoglobulin A (IgA) therapy.

Important Safety Information

Gammagard Liquid 10% 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.

Black Box Warning: IGIV 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 IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gammagard Liquid 10% does not contain sucrose.

Gammagard Liquid 10% 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 IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered.

visit www.baxter.com/products/biopharmaceuticals/antibody_therapies/index.html for full prescribing information.

Source: Baxter healthcare www.baxter.com

Posted: May 2005


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