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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

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 birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients).

About Motavizumab

Motavizumab, formerly known as Numax(R), is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Phase 1 and Phase 2 study data have been reported showing that motavizumab appears to have a similar safety and pharmacokinetic profile to Synagis in infants. Additionally, in early phase studies children treated with motavizumab had reduced RSV replication in the upper respiratory tract. In its first pivotal trial, which was a head-to-head comparative trial with Synagis, motavizumab demonstrated a 26-percent reduction in RSV hospitalizations due to RSV and a 50-percent reduction in the incidence of RSV lower respiratory tract infections requiring outpatient management, its secondary endpoint.

About Synagis

Synagis is the only monoclonal antibody approved by the FDA to help prevent an infectious disease. Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries.

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RS
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SOURCE MedImmune, Inc.
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