MedImmune's RespiGam
Executive Summary
Halts clinical trial program for the treatment of respiratory syncytial virus. The decision, announced July 27, follows "an analysis of data from two recently completed trials." A PLA for the polyclonal antibody-based hyperimmune globulin product for the prevention of RSV in high-risk infants is under review at FDA, and an additional Phase III trial for the prevention of RSV is scheduled for completion in 1995. RespiGam was turned down by an FDA advisory committee on Dec. 2 because of concerns about compromised data