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

thday. Children born prematurely as well as those with 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 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.

About Synagis

Synagis is the only MAb approved by the U.S. Food and Drug Administration (FDA) to help prevent an infectious disease. Since its licensure in 1998, Synagis has been administered to more than 1,000,000 infants in the U.S. and has become the standard of care for infants at high risk for RSV. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere during the winter months. Synagis is a humanized MAb given by an intramuscular injection once a month during the RSV season. Synagis was approved in 1998 by the FDA; in 1999, by the European Medicines Evaluation Agency; and in 2002, by the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded the U.S. label for Synagis for use in young children with hemodynamically significant CHD at risk of RSV disease. To date, Synagis has been approved in 62 countries, including the United States. Synagis is indicated for the prevention of serious lower respiratory t
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