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FDA APPROVES GAMIMUNE N IN THE TREATMENT 0F PEDIATRIC AIDS AND BONE MARROW TRANSPLANT PATIENTS

 WEST HAVEN, Conn., Jan. 13 /PRNewswire/ -- Gamimune N, Immune Globulin Intravenous (Human), a biological product manufactured and marketed by the Pharmaceutical Division of Miles Inc., was recently approved by the Food and Drug Administration for two new indications, Miles announced.
 The new indications for Gamimune N are for 1) decreasing the frequency of serious and minor bacterial infections and the frequency of hospitalization and to increase the time free of serious bacterial infections in pediatric patients with Human Immunodeficiency Virus (HIV) and 2) for use as a prophylaxis in bone marrow transplant patients 20 years of age or greater.
 In multi-center clinical trial pediatric data submitted to the FDA, investigators found that HIV-infected children who received Gamimune N experienced a significant decrease in the rate of bacterial and viral infections. The double-blind, placebo-controlled study involved 369 patients over 18 months.
 While Gamimune N was found to be effective in prolonging infection-free time in HIV-infected children in the study, there was no difference in mortality between placebo controlled patients and those receiving the drug.
 In a controlled study of 369 bone marrow transplant patients (one half treated and the other half control patients) conducted at the Fred Hutchinson Cancer Research Center in Seattle, Gamimune N was shown to decrease the risk of septicemia and other infections, interstitial pneumonia and acute graft-versus-host disease in the first 100 days post-transplant.
 Gamimune N, an immune globulin fractionated from human plasma and administered intravenously, is also indicated for treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura. The product was originally introduced in 1986. The additional indications were approved on Dec. 27, 1993, by the FDA. It is manufactured by the company's Biological Products unit at its plasma fractionation facility in Clayton, N.C.
 Miles Inc. is a research-based company with major businesses in chemicals, health care and imaging technologies. Headquartered in Pittsburgh, the company employs some 26,000 people and had sales of more than $6.5 billion in 1993. Miles has 57 locations throughout North America.
 -0- 1/13/94
 /CONTACT: Donald Hyman of Miles, 203-498-6545, or evenings, 203-255-9093/


CO: Miles Inc. ST: Connecticut IN: MTC SU: PDT

CK-WB -- NY005 -- 1745 01/13/94 10:03 EST
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Publication:PR Newswire
Date:Jan 13, 1994
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