Drug may reduce infant hospitalization
Drug may reduce infant hospitalization
A recent study shows that prophylactic infusions of RespiGam reduce respiratory syncytial virus (RSV) hospitalizations among premature infants and those with bronchopulmonary dysplasia.
The study was a placebo-controlled clinical trial conducted at 54 sites across the United States. The incidence of RSV hospitalization was reduced by 41% among children receiving RespiGam. Thirty-five (13.5%) of the children in the placebo group were hospitalized for RSV, vs. just 20 (8%) children receiving RespiGam.
In addition, RespiGam recipients had a 53% reduction in the total number of RSV hospital days per 100 children, a 60% reduction in the number of RSV hospital days with increased oxygen requirement, and a 54% reduction in the number of RSV hospital days with a moderate or severe lower respiratory tract illness. Also, children in the RespiGam group had a 38% reduction in hospitalization for respiratory illness of any cause and a 46% reduction in total hospital days for respiratory illness per 100 children.
The drug was shown to be safe and generally well tolerated. Its safety profile is similar to that of intravenous infusion of other immune globulin preparations. Based primarily on the study, the U.S. Food and Drug Administration licensed RespiGam for marketing early last year for the prevention of serious RSV disease in children less than 24 months old with bronchopulmonary dysplasia or a history of prematurity.
The study, known as PREVENT, was sponsored by MedImmune, who along with Wyeth-Lederly Vaccines and Pediatrics, is launching the drug.
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