CYTOMEGALOVIRUS IMMUNE GLOBULIN WILL BE MADE AVAILABLE TO ALL KIDNEY TRANSPLANT PATIENTS IN MASSACHUSETTS UNDER FIRST NON-AIDS TREATMENT IND

Cytomegalovirus immune globulin will be made available to patients undergoing kidney transplants in Massachusetts hospitals under the first non-AIDs Treatment IND granted by FDA according to its new investigational regs. The Treatment IND was granted the week of Oct. 19 to the Massachusetts Department of Public Health, which manufactured and tested CMV-IG in a multi-center controlled clinical trial. The approval of a Treatment IND indicates that FDA believes that there is some clinical evidence supporting the efficacy of CMV immune globulin as a way to protect kidney transplant patients against severe CMV infections until patients' immune systems return to normal. "In the case of kidney transplant patients infected with CMV," the agency says, "there is no currently approved therapy, and therefore, this experimental biological product given prophylactically may provide the only alternative." The Massachusetts Department of Public Health has filed a product license application for CMV-IG with FDA. Initially, the product will be available only to transplant centers in Massachusetts, the state health agency indicated. However, Massachusetts said it plans to expand the product's availability when production capacity permits. Prior to the IND for CMV-IG, Burroughs-Wellcome's Retrovir was made available to a wide number of AIDS patients under procedures similar to the Treatment IND regs. FDA has designated CMV-IG an orphan drug. The biological product is made from normal human blood plasma containing high titers of CMV antibodies. "Researchers at the Massachusetts Public Health Biologic Laboratories extracted CMV antibodies from the blood of people who had already developed immunity," according to a press release from the state health department. "The antibodies were then concentrated and administered to transplant patients who received infected kidneys but had no antibodies in their own blood to protect them from the virus." The results of a study, in which multiple doses of CMV-IG were given intravenously to patients before infection, were published in the Oct. 22 issue of The New England Journal of Medicine. Transplant patients "showed a decrease of two-thirds in CMV disease," the release explains. In the prospective randomized clinical trial, 59 CMV-seronegative patients "who received kidneys from donors who had antibodies against CMV were assigned to receive either intravenous CMV immune globulin or no treatment," the journal article reports. In terms of clinical outcome, "the attack rate for virologically confirmed CMV syndromes was reduced from 60 to 21 percent with the use of prophylactic CMV immune globulin," the article says. "Furthermore, there was a significant reduction in the rate of complications due to fungal or parasitic infections in the group receiving globulin." The kidney transplant recipients at highest risk for CMV disease are CMV-seronegative patients who receive transplants from CMV-seropositive donors. "In this population, the risk of CMV-associated morbidity approaches 60 percent," according to the study. The investigators stressed, therefore, that the results "should apply to all CMV-seronegative patients who receive kidney transplants from seropositive donors."