FDA questions motavizumab safety

FDA questioned the risk-benefit profile of motavizumab in briefing documents posted ahead of Wednesday's Antiviral Drugs Advisory Committee meeting to discuss the humanized RSV antibody from MedImmune LLC to prevent serious respiratory syncytial virus (RSV). The documents noted that motavizumab has three times as many non-fatal hypersensitivity adverse events, including urticaria, compared to MedImmune's marketed Synagis palivizumab, with an overall rate of about 1%. Although no episodes of life-threatening anaphylaxis reactions were observed in clinical trials, FDA said the number of patients exposed is too small to detect an event that may occur in a larger population. ...