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news.MedImmune has submitted a biologics license application to the FDA for motavizumab, an investigational monoclonal antibody derived from recombinant DNA technology.
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The company said that the motavizumab biologics license application (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.
Linda Peters, senior vice president, regulatory affairs, said: “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.”