FDA Licenses IGIV For Two New Indications

Date: January 3, 1994
Source: Food and Drug Administration (FDA)

We have been receiving inquiries about FDA's recent licensing of Immune Globulin Intravenous (Human) (IGIV) to treat children with AIDS and bone marrow transplant patients. The following can be used to answer questions.

IGIV manufactured by Miles Inc. is now indicated for HIV-infected children to decrease the frequency of bacterial infections, increase the time free from serious bacterial infections, and decrease the frequency of hospitalizations.

In a multi-center, double-blind, placebo-controlled trial including 394 HIV-infected children under 13 years of age, treatment with IGIV resulted in decreases of 41 percent in serious bacterial infections and 37 percent in hospitalizations per 100 patient years as compared to placebo. Adverse reactions were uncommon, and included fever, irritability, flushing, itching, vomiting, chills and cough.

The second new indication for IGIV manufactured by Miles Inc. is treatment of bone marrow transplant patients over 20 years of age who are at increased risk of complications such as infections and graft-versus-host disease. These complications are major difficulties in the first 100 days following bone marrow transplants.

Data from a controlled clinical trial enrolling 383 bone marrow transplant patients indicated that IGIV provided significant reduction in the frequency and severity of infection and of graft-versus-host disease in patients over age 20. There was little or no benefit to patients under 20. Adverse reactions, occurring in fewer than 1 percent of treatments, included chills, headache, flushing, fever, itching and slight back discomfort.

IGIV was first licensed in 1981 as an alternative to intramuscular Immune Globulin (Human) for the treatment of immunodeficiency syndromes. Since then, five other companies have been licensed to manufacture IGIV, and the indications for IGIV have expanded to include the treatment of idiopathic thrombocytopenic purpura, a disorder resulting in low platelet levels and a risk of serious bleeding; Kawasaki syndrome, a disease of children that may result in coronary artery abnormalities; and chronic lymphocytic leukemia.

IGIV manufactured by Miles Inc. of Berkeley, Calif., is sold under the trade name Gamimune N.