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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Motavizumab reduced hospitalization in Phase III trial: MedImmune's motavizumab reduced hospitalizations due to respiratory syncytial virus by 83 percent compared to placebo in a Phase III trial, the firm says May 4. The monoclonal antibody is being evaluated for its potential to prevent serious disease caused by RSV in high-risk pediatric patients. The trial showed a 71 percent reduction in the incidence of RSV-specific lower respiratory infections requiring outpatient management, which was the study's secondary endpoint. The randomized, double-blind study involved 1,410 full-term healthy infants less than six months old in certain Southwest Native American populations and was designed to compare monthly intramuscular injections of motavizumab against placebo. The study confirmed what previous epidemiological studies have shown: that these populations have high rates of hospitalization due to RSV. Motavizumab would be a follow-on to AstraZeneca's Synagis (palivizumab)

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