MedImmune announced that the FDA has granted Fast Track designation to MEDI8897 for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

MEDI8897 is being developed for the passive immunization of all infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season for the prevention of LRTI caused by RSV. MEDI8897 is currently being investigated in a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of the antibody in healthy adults. Based upon analysis of interim data from this study, a separate Phase 1b/2a study has been initiated to examine MEDI8897 in healthy preterm infants.

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MEDI8897 is an investigational recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) with an extended half-life that neutralizes RSV by binding the prefusion conformation of the RSV fusion (F) protein expressed on virions and infected cells.

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