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Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting
Date:5/4/2008

disease. Phase 1, 2 and 3 study data have been reported showing that motavizumab appears to have a similar safety and pharmacokinetic profile to Synagis(R) (palivizumab) in infants. Additionally, in early phase studies children treated with motavizumab had reduced RSV replication in the upper respiratory tract. In its pivotal clinical trial, which was a head-to-head comparative trial with Synagis, motavizumab demonstrated non-inferiority with a 26-percent relative reduction in RSV hospitalizations due to RSV, which was its primary endpoint, and a 50- percent relative reduction in the incidence of RSV lower respiratory tract infections requiring outpatient management, one of its secondary endpoints. Rates of adverse events, serious adverse events and study drug discontinuations were balanced between treatment groups.

About Synagis

Synagis (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.

Synagis is not currently recommended as a preventive measure among Native American infants at high risk for serious RSV disease.

Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Other side effects with Synag
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SOURCE MedImmune
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