The FDA has licensed Baxter Healthcare Corp.'s Hyland Division tomarket Gammagard S/D, an improved version of its Gammagardproduct that was withdrawn from the market in February because ofsafety concerns. The product is used primarily in people withpotentially life-threatening immune disorders. It is a highly purifiedpreparation of human immunoglobulin G (IgG).Gammagard S/D is biologically and clinically equivalent to the originalproduct, according to Alan Kofsky, global products manager forGlendale, Calif.-based Hyland. However, the new version of thepreparation is manufactured using a process that incorporates anadditional viral purification procedure. The new step involves treatingthe IgG preparation with an organic solvent and two detergents toinactivate any blood-borne viruses.This process is intended to avoid problems reported in some patientswho developed laboratory or clinical symptoms of hepatitis C whileusing the original product. Although the product was withdrawn fromsale, Kofsky told BioWorld that those claims are still beinginvestigated and none have yet been documented.Gammagard S/D is indicated as an antibody replacement therapy in thetreatment of three diseases: primary immunodeficiencies associatedwith hereditary diseases caused by a genetic defect, B-cell chroniclymphocytic leukemia and acute idiopathic thrombocytopenic purpura.In addition to safety, the new product has the advantage of being ableto be administered in a 10 percent concentration, compared to 5 percentin the original. This reduces the time required for the infusion. In somecases, the infusion period has been cut from three hours to 30 minutes,Kofsky said. _ Philippa Maister
(c) 1997 American Health Consultants. All rights reserved.