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.