GAITHERSBURG, Md., Feb. 4 /PRNewswire/ -- MedImmune announced today it submitted to the U.S. Food & Drug Administration (FDA) on January 30 a Biologics License Application (BLA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology. The motavizumab BLA is supported by clinical trial data from more than 6,000 patients in which safety and efficacy in prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients were evaluated.
"We are pleased to submit this BLA for motavizumab, which we believe represents another tool in the fight against RSV. This marks a significant milestone for this molecule and further reinforces MedImmune's commitment to developing anti-RSV biologics for the underserved pediatric patient population," said Linda J. Peters, senior vice president, regulatory affairs.
Motavizumab was studied in an active-controlled Phase 3 trial against the standard of care in pediatric patients at high risk of serious RSV disease. Primary and secondary endpoints of the study included incidence of RSV hospitalizations and RSV-specific medically attended outpatient lower respiratory tract infections. Rates of adverse events, serious adverse events and study drug discontinuations were balanced between treatment groups. The most frequently observed reactions versus the active comparator were cutaneous reactions (overall).
"Beyond the findings of the various investigational trials for motavizumab, we believe this molecule will help reinforce the positive role that MAbs play in RSV prevention within the current clinical body of evidence. It also reinforces our position as a leader in RSV prevention," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease.
RSV is a leading cause of viral respiratory infection among infants.
Each year, up to an estimated 125,000 infants in the United States are
hospitalized with sev
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