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.

"Abbott is pleased the use of Synagis is being broadened to help protect vulnerable infants and children with CHD from a potentially life-threatening RSV infection," said Guillermo Herrera, senior vice president, international operations, Abbott Laboratories.

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.

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.