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European CPMP Adopts Positive Opinion On Synagis For Prevention Of RSV ABBOTT PARK, IL and GAITHERSBURG, MD -- May 21, 1999 -- The European Union’s committee for proprietary medicinal products has adopted a positive opinion on Abbott Laboratories’ and MedImmune, Inc.’s Synagis(TM) (palivizumab), a monoclonal antibody developed for the prevention of a serious lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is the most common cause of lower respiratory infections in infants and children world-wide. The CPMP opinion now will be considered by the European Commission, which will make a final decision regarding the issue of a marketing authorisation. Synagis will be the only preventive treatment in Europe for RSV in pediatric patients under two years old who suffer from lung problems due to chronic broncopulmonary dysplasia (BPD) or prematurity (less than or equal to 35 weeks gestational age). Synagis is administered monthly during peak RSV season with an intramuscular (IM) injection to pediatric patients at high risk from RSV. During the peak season in Europe, more than 50 percent of hospitalisations due to respiratory infections in children under two involve RSV. Recommendation for approval of Synagis is based on a large, randomised study demonstrating a 55 percent reduction in the incidence of hospitalisation due to RSV infections in high-risk pediatric patients. Related Links: Abbott Laboratories, MedImmune, Inc. E-mail this page to a friend or colleague! To print, use this version