Abbott Laboratories announced that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted a positive opinion for Synagis (palivizumab) use in young children born with congenital heart disease (CHD) to prevent respiratory tract infection caused by respiratory syncytial virus (RSV). RSV is the most common cause of lower tract respiratory infections in infants and children worldwide, typically occurring during late fall, winter and early spring.

Synagis is a humanized monoclonal antibody approved by the EMEA and the U.S. Food and Drug Administration (FDA) to prevent lower respiratory tract infection caused by RSV in premature infants at high risk of RSV disease. Synagis was originally approved by the EMEA in 1999. The European Commission is expected to issue a marketing authorization for the new indication for Synagis in European Union (E.U.) countries in approximately 90 days. Abbott filed for E.U. approval of this indication in March 2003.

Congenital heart defects are structural problems of the heart that are present at birth and can vary in type and degree of severity. An estimated four of every 1,000 infants in Europe are born with some type of CHD. Children born with serious CHD who have decreased cardiac or pulmonary reserve are at higher risk of serious RSV infection. These children have been shown to require intensive care and use mechanical ventilation more frequently than children without CHD. Additionally, children with CHD who are hospitalized with RSV have a mortality rate that is three times greater than children without CHD.

The regulatory submission was based on a four-year, double-blind, placebo-controlled study assessing 1,287 children less than two years of age with serious CHD. In the study, children were randomized to receive monthly intramuscular injections (15 mg/kg) of either Synagis (n=639) or placebo (n=648) for a period of five months during the RSV season, which in the Northern Hemisphere lasts from October through April. The study was conducted at 75 centers in France, Germany, North America, Poland, Sweden and the United Kingdom, and was completed in 2002.

The Synagis group had nearly 50 percent fewer hospitalizations due to RSV (p=0.003) compared to the placebo group, with a total of 34 patients compared to 63 patients requiring hospitalization. Further, the data showed there were significantly fewer RSV-related hospital days (p=0.003) and fewer days of increased oxygen usage (p=0.014) in the treated group than in the placebo group. The adverse events reported in the two treatment groups were similar. The most common adverse events reported were injection site reaction and fever.

For children with chronic lung disease and premature infants who are 35 weeks gestational age or less, clinical studies have demonstrated that Synagis was safe and effective.

Abbott has exclusive rights to Synagis in markets outside of the United States. In the United States, MedImmune and Abbott have an exclusive agreement to co-promote Synagis.