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MedImmune's Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
Date:8/23/2007

V disease and is administered by intramuscular injection. The safety and efficacy of Synagis were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of prematurity (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to commencement of the RSV season, which usually starts in the fall and runs through the spring. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.

Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.

In clinical trials, the most common adverse events occurring at least one percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.

The pivotal trial for Synagis was called the IMpact trial and comprised a total of 1,502 children who were randomized (500 placebo, 1,002 Synagis) in a double-blind, placebo-controlled protocol where 1,486 children completed the study's follow-up.

In the IMpact trial, monthly prophylaxis with Synagis via intramuscular injections was associated with a 55-percent reduction in hospitalization as a result of RSV (p=<0.001). Reductions were observed in both children with bronchopulmonary dysplasia (38 percent reduction) and premature children without BPD (78 percent reduction). Approximately 50 percent of the
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SOURCE MedImmune, Inc.
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