MedImmune Submits Biologics License Application to FDA for Motavizumab.
PR Newswire Europe, February, 2008
GAITHERSBURG, Maryland, February 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...
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