Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.MedImmune's researchers has presented positive results from Phase III study involving motavizumab, an investigational monoclonal antibody that is being evaluated for its potential to prevent serious disease caused by respiratory syncytial virus in high-risk pediatric patients.
Subscribe to our email newsletter
This randomized, double-blind study has demonstrated that motavizumab reduced hospitalizations due to respiratory syncytial virus (RSV) by 83% as compared to placebo (8.3% in placebo arm versus 1.4% in motavizumab; p<0.001), as the trial's primary endpoint. In addition, the trial showed a 71% reduction in the incidence of RSV-specific lower respiratory infections (LRIs) requiring outpatient management (9.5% in placebo group and 2.8% in the motavizumab group; p<0.001), which was a secondary endpoint. The study involving 1,410 full-term healthy infants less than six months of age in some southwest native American populations was designed to compare monthly intramuscular injections of motavizumab against placebo. In previous epidemiologic studies these populations were shown to have high rates of hospitalization due to RSV. This study confirmed the high rates of serious RSV disease in this population. An interim analysis, reviewed by an independent data safety monitoring committee, concluded there was statistical evidence demonstrating that motavizumab reduced RSV hospitalizations and LRIs requiring outpatient medical management within this population.