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CYTOMEGALOVIRUS IMMUNE GLOBULIN I.V. APPROVED FOR KIDNEY TRANSPLANT

Executive Summary

CYTOMEGALOVIRUS IMMUNE GLOBULIN I.V. APPROVED FOR KIDNEY TRANSPLANT patients "who show no signs of infection with cytomegalovirus prior to their surgery, but who are receiving kidneys from cytomegalovirus positive donors," HHS announced April 17. Developed by the Massachusetts Public Health Biologic Laboratories, CMV-IGIV has been available to appropriate kidney transplant patients since October 1987 under a Treatment IND. Through the expanded access investigational program, 166 kidney transplant patients have received the orphan product to date. The American Red Cross, Northeast Region, has distributed the product under the Treatment IND and will continue to do so now that CMV-IGIV is approved. CMV-IGIV was the first Treatment IND approved by FDA after publication of the Treatment IND and Sale regulation. Under the cost recovery provisions of the reg, the Massachusetts Department of Public Health has been charging $250 for a vial of CMV-IGIV. The average course of therapy for an adult kidney transplant patient is 20-24 vials, depending on the patient's weight. The state's current plans are to continue to charge $250/vial for the product. Because of initial supply concerns, the Red Cross will be closely monitoring orders for CMV-IGIV to ensure that only appropriate patients are getting the plasma-derived product. The state hopes to scale up production and eliminate the supply problem in about nine months. The approval of CMV-IGIV was based on a randomized controlled trial in 31 kidney transplant patients and an open study in 36 patients. The studies, which were supported with grants from the National Institutes of Health, "demonstrated that CMV-IGIV could dramatically reduce the incidence of severe cytomegalovirus infection in kidney transplant patients, and indicated that it might also reduce related deaths," according to HHS. CMV-IVIG is also being evaluated in liver patients. The double-blind, NIH-sponsored study is scheduled to end at the close of April.
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PS017294

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