Licensure of palivizumab (SynagisTM(MEDI-493)) for prophylaxis of respiratory syncytial virus (RSV) disease was granted June 19 by the U.S. Food and Drug Administration. Palivizumab is an intra-muscularly administered monoclonal antibody preparation.

The approval of palivizumab was based on a large, randomized study demonstrating a 55 percent reduction in the risk of hospitalization due to RSV infections in high-risk infants and toddlers. Both palivizumab and respiratory syncytial virus immune globulin intravenous (RSV-IGIV) are available for protecting high-risk infants and toddlers against serious complications from RSV infections. RSV-IGIV is contraindicated and palivizumab is not recommended for children with cyanotic congenital heart disease.

This content is only available via PDF.
You do not currently have access to this content.