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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

Native American infants, with an overall incidence and severity of adverse events (AEs) that were similar between the motavizumab and the placebo groups. The mortality rates were not statistically different between groups (0.4 percent in the placebo arm, n=2 and 0.3 percent in the motavizumab arm, n=3) and were not considered to be related to the study drug. As was suggested in the pivotal Phase 3 trial conducted in high-risk, preterm infants, rates of hypersensitivity related skin rashes within two days of dosing were seen in about one percent of treated children in the motavizumab group.

MedImmune's Commitment to RSV Prevention

MedImmune is a world leader in the development of innovative therapeutic biologic products to prevent RSV disease. In 1996, MedImmune launched the first anti-RSV drug, RespiGam(R) (respiratory syncytial virus immune globulin intravenous (human) (RSV-IGIV)), which was a polyclonal antibody administered via four-hour intravenous infusion. In 1998, MedImmune introduced Synagis, which was a significant product improvement as a monthly intramuscular injection for the prevention of severe RSV, as well as being the first MAb to receive U.S. Food and Drug Administration (FDA) approval for an infectious disease. With the development of motavizumab, MedImmune continues to reinforce its commitment to developing anti-RSV products. In a head-to-head comparative Phase 3 trial with Synagis, motavizumab met its primary endpoint of reducing RSV-related hospitalizations in high-risk pediatric patients and met its secondary endpoint of reducing medically attended, outpatient respiratory tract infections in that patient group. MedImmune is also developing a small-molecule product candidate to prevent RSV as well as a vaccine against RSV, both of which are in Phase 1 clinical trials.

About RSV

Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections
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SOURCE MedImmune, Inc.
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