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MEDIMMUNE’s RESPIGAM REDUCED SEVERE RESPIRATORY INFECTIONS 72%

Executive Summary

MEDIMMUNE's RESPIGAM REDUCED SEVERE RESPIRATORY INFECTIONS 72% in children at risk of respiratory & syncytial virus infection, in a study by Jessie Groothuis, MD, et al., published in the Nov. 18 New England Journal of Medicine. The study looked at 249 infants and young children with cardiac disease or prematurity who were at risk for RSV. The 81 recipients of high-dose RespiGam (formerly Respivir) respiratory syncytial virus immune globulin "had a 62% reduction in the incidence of [RSV] infection of the lower respiratory tract (p = O.O1) and a 72% reduction in all moderate or severe [RSV] infections of the lower respiratory tract (p = 0.03)," the study reports. The 79 children receiving "a low-dose infusion had a reduction of only 27% in the overall frequency of [RSV] infections of the lower respiratory tract, as compared with the controls (p = O.35), and a reduction of 53% in moderate or severe [RSV] infection of the lower respiratory tract (p = O.13)," the study notes. Infants and children in the study received either monthly infusions of RespiGam in a high dose (750 mg/kg of body weight), monthly RSV immune globulin in a low dose (150 mg/kg) or no immune globulin. The infusions were given during December through March or April, when most RSV infections occur, over a three-year period. Children receiving high-dose immune globulin "were hospitalized 63% less often than control children and spent significantly fewer total days in the hospital for respiratory syncytial virus disease (a 63% reduction)," the study states. There were fewer ICU admissions in the low-dose and high-dose groups than in the control group and "the total number of days in the [ICU] was reduced by 97%-100% over that for the controls." The study notes that "two children in the control group and none in either treatment group required assisted ventilation." In addition, "a significant decrease in the number of days of ribavirin [ICN Pharmaceuticals' Virazole] use was also observed in the high-dose group (9 per 100 children) as compared with the control group (33 per 100 children, p = 0.05)." Although treatment effects were seen in all three groups, the study notes that "the greatest improvement was among preterm infants and infants with bronchopulmonary dysplasia." A PLA for RespiGam's use in preventing RSV in at-risk children will be reviewed by FDA's Blood Products Advisory Committee on Dec. 2 at the Ramada Inn, Bethesda, Md., beginning at 8 a.m. RSV causes more than 91,000 hospitalizations per year and contributes to 4,500 deaths each year, the study investigators said. MedImmune licenses RespiGam from the Massachusetts Public Health Biologic Laboratories. Groothuis, principal investigator of the Respiratory Syncytial Virus Immune Globulin Study Group, is also an associate professor of pediatrics at the University of Colorado and director of the neonatal high-risk follow-up program at The Children's Hospital in Denver. The National Institute of Allergy and Infectious Diseases was one of the study's sponsors.
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