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| |  Synagis Approved In Europe For Prevention Of RSV ABBOTT PARK, IL and GAITHERSBURG, MD -- Sept. 1, 1999 -- The European Commission has approved Abbott Laboratories’ and MedImmune, Inc.’s Synagis(TM) (palivizumab) for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in high-risk infants. Synagis is indicated for use in infants born prematurely (less than or equal to 35 weeks gestational age), and infants and children with chronic bronchopulmonary dysplasia (BPD), a chronic lung disease. Synagis is the first product to deliver safe and effective RSV protection with a simple intramuscular (IM) injection. The injection can be administered in the primary health-care provider's office once a month during the RSV season -- typically November to April in Europe. RSV is the most common cause of lower respiratory infections in infants and children world-wide. In fact, half of all children around the world develop RSV infections by the age of one year, and by the age of two, virtually all children have been infected. In high-risk children infected with RSV, 70 percent may require hospitalisation, 25 percent may require mechanical ventilation and some may die as a result of RSV infection. A placebo-controlled, randomised study -- one of the largest studies ever conducted in premature infants -- showed Synagis reduced the risk of hospitalisation due to RSV by 55 percent. Studies were conducted in premature infants, including those with BPD. The most frequently reported adverse reactions were fever, nervousness and injection site reaction, however these rates were similar in the treatment versus placebo groups. In addition to its success in preventing RSV, Synagis does not interfere with normal childhood vaccines including the measles-mumps-rubella vaccine and the varicella virus vaccine. Common symptoms of RSV include a low-grade fever, runny nose and cough. The cough may be accompanied by wheezing and difficulty in breathing, which can indicate that the virus has moved to the lower respiratory tract. RSV spreads easily from person to person via sneezing or coughing, or from hands touching the nose or eyes and then coming in contact with another person or object. The chance of spreading the virus within a family is very high. Many times, school-aged children introduce the virus into the family. Despite strict infection control procedures, hospital nursery units, day-care centres and other similar institutions are also at high-risk for RSV outbreaks.
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