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MedImmune Announces Positive Clinical Results at PAS Annual Meeting,From Large Prospective Trial in Prevention of Serious RSV Disease

ence and severity of adverse events (AEs) were comparable for both treatment groups and were consistent with prior experience with Synagis. There were comparable rates of related AEs and drug discontinuations between treatment groups [related AEs: motavizumab (N=298, 9.0 percent) vs. Synagis (N=258, 7.8 percent) p=not significant (NS); discontinuations: motavizumab (N=13, 0.4 percent) vs. Synagis (N=10, 0.3 percent) p=NS]. AEs related to skin hypersensitivity reactions resulted in discontinuation of dosing in motavizumab-treated patients at low frequency (N=9, 0.3 percent). In Synagis-treated patients, there were no AEs consistent with skin hypersensitivity reactions that resulted in dosing discontinuation. The overall mortality rates were not statistically different between the two groups (N=8, 0.2 percent motavizumab and N=4, 0.1 percent Synagis); no death was considered to be related to the study drugs and there were no RSV-related deaths. Immunogenicity in the motavizumab arm was less than 1 percent and comparable to the historical Synagis rate.

The trial was a randomized, double-blind study involving 6,635 high-risk infants at 347 centers in 24 countries through three RSV seasons. Study participants comprised premature infants born at 35 weeks gestational age or less who were six months of age or younger at randomization, as well as children with CLD related to prematurity requiring medical management within the six months prior to study entry, who were 24 months of age or less at randomization.

About RSV

Each year, an estimated 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second bir
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