FDA's Newly Designated Treatment INDs

Abstract

WE HEREIN describe two new investigational drugs, cytomegalovirus immune globulin and trimetrexate glucuronate, that physicians may obtain under treatment protocols for certain patients with the serious or life-threatening conditions for which the drugs are indicated. The drugs have been approved for early availability under special IND procedures by the commissioner of the Food and Drug Administration. CYTOMEGALOVIRUS IMMUNE GLOBULIN Background Cytomegalovirus immune globulin (CMVIG), the subject of a Treatment IND, is sponsored by the Massachusetts Public Health Biologic Laboratories, Division of the State Laboratory Institute, Department of Public Health, The Commonwealth of Massachusetts, Boston. The product is indicated for the attenuation of primary cytomegalovirus (CMV) disease associated with kidney transplantation in seronegative recipients of kidneys from seropositive donors. Approximately 75% of untreated seronegative recipients would be expected to develop CMV infection. 1 Clinical studies have shown a 50% reduction in primary CMV disease in renal transplant recipients given CMVIG.