New Data Presented at Neonatology Conference Suggest More Needs to Be Done To Protect At-Risk Infants From Respiratory Syncytial Virus Start of RSV Season Puts Infants at Risk of Infection WASHINGTON, Dec. 12 /PRNewswire-FirstCall/ -- New clinical data provide additional evidence that premature [i.e., less than or equal to 35 weeks gestational age (wGA)] infants are at elevated risk for respiratory syncytial virus (RSV)-related morbidity and mortality. Data presented this week by a panel of leading neonatologists and infectious disease specialists at an international neonatology conference identify those infants at greatest risk for serious disease and alert physicians that the RSV season is underway in the northern hemisphere. "These new findings help raise awareness of the risks of RSV in premature babies," said Jessie Groothuis, M.D., global medical director, Immunology Development, Abbott Laboratories. "Preventive treatments can help protect these already vulnerable infants against RSV, a serious lower respiratory tract disease." RSV is the most common cause of lower respiratory tract infections (LRTI) such as bronchiolitis and pneumonia in infants and children worldwide, with infections predominantly occurring between the autumn and spring. Nearly 50 percent of bronchiolitis and 25 percent of pneumonia hospitalizations in young children are caused by RSV. The global annual infection and mortality figures for RSV are estimated to be as high as 64 million and 160,000, respectively. Those considered at the highest risk for RSV disease include preterm infants and infants with hemodynamically significant congenital heart disease (CHD). Synagis(R) (palivizumab), approved in Europe in 1999 and in the United States in 1998 to prevent serious RSV infections in high-risk premature infants, was recently approved in Europe for expanded use in children up to 2 years of age with CHD (October 2003), and in the United States for use in infants and young children up to the age of 2 years with CHD (September 2003). Three international studies presented for the first time at Hot Topics, an international conference held this week in Washington, D.C., underline the need for high-risk infants to receive preventive treatments, which may result in fewer RSV-related hospitalizations. In addition, data being released for the first time target specific risk factors for RSV hospitalization in premature infants. Danish Study Shows RSV Prophylaxis Encouraged Findings from a recent Danish study of extremely premature infants, with or without chronic lung disease, indicated that these patients are at unusually high risk of rehospitalization and are often in need of respiratory support due to complications resulting from RSV infection. The study authors concluded that consideration should be given to more widespread application of RSV prophylaxis in this high-risk patient population. Spanish Study Shows Synagis Results in 70 Percent Fewer Hospitalizations Results from a four-year Spanish study, published in the October 2003 issue of Pediatric Infectious Disease Journal, demonstrated that premature infants less than or equal to 32 wGA prophylaxed with the monoclonal antibody Synagis experienced 70 percent fewer RSV-related hospitalizations than those not receiving Synagis. Overall, infants who did not receive Synagis were almost four times more likely to have RSV-related hospitalizations. International Studies Identify New Risk Factors for RSV in Premature Infants A recent study published in The Journal of Pediatrics demonstrated that infants born 33-35 wGA experience severe hospital outcomes comparable to infants less than 33 wGA. At Hot Topics, investigators from Canada and Spain presented separate studies designed to identify the risk factors most likely to contribute to RSV infection and hospitalization in infants born at 33-35 wGA. According to data presented by Drs. Barbara Law of Canada and Xavier Carbonell of Spain, risk factors for hospitalization included siblings in day care, household crowding, the presence of smokers in the home, male gender, multiple health conditions, an age of 10 weeks or younger at the start of the RSV season, and early discontinuation of breastfeeding. RSV and High-Risk Infants Preterm infants represent the largest group of children at high risk for serious RSV infection, re-infection and hospitalization. Studies have shown that children at increased risk of complications from RSV disease include infants born prematurely. RSV infection, when severe enough to result in hospitalization, may require intensive care and mechanical ventilation. High-risk infants who contract RSV are significantly more likely than healthy, term infants to develop LRTI such as bronchiolitis and pneumonia, conditions that often require lengthy and costly hospitalizations. Over the long term, RSV infection has been linked to chronic wheezing and coughing similar to childhood asthma. RSV Prophylaxis with Synagis (palivizumab) Synagis, a humanized monoclonal anti-RSV antibody, is currently the only preventive regimen against LRTI hospitalization caused by RSV. Prophylaxis with Synagis involves monthly intramuscular injections throughout the RSV season. Synagis has been proven to bind to all clinical RSV isolates collected worldwide and is licensed in more than 50 countries. Synagis is indicated for children less than 2 years of age with bronchopulmonary dysplasia/chronic lung disease, premature infants less than or equal to 35 wGA, and for infants and children 2 years of age or younger with hemodynamically significant CHD. Previous clinical studies have demonstrated that Synagis is effective and well-tolerated. Common adverse events included fever and injection site reactions but these were not significantly greater than placebo. Abbott Laboratories has exclusive rights to Synagis in markets outside of the United States. In the United States, MedImmune Inc. (Gaithersburg, MD, USA) and Abbott have an exclusive agreement to co-promote Synagis. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott Laboratories CONTACT: Media, Donna Lindquist, +1-847-936-1192, or Financial Community, John Thomas, +1-847-938-2655, both of Abbott Laboratories Web site: http://www.abbott.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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