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New Study in Journal of Pediatrics Suggests Synagis (Palivizumab),May Reduce Subsequent Recurrent Wheezing in Preterm Infants

ollowed by a healthy period of at least one week. The study also evaluated the incidence of physician-diagnosed recurrent wheezing, defined as three or more episodes of wheezing in the prior 12 months, as verified by a physician at a physician's office, emergency room or hospital.

Clinical Trial Results

After following these infants for two years, the results showed the following key findings:

The incidence of recurrent wheezing was 49 percent lower among children who received Synagis compared to those who did not (13 percent vs. 26 percent, p=0.001). There was also significantly less physician-diagnosed recurrent wheezing in the group that received Synagis (8 percent vs. 16 percent, p=0.011).

In addition, infants who received Synagis had a significantly longer time to onset of both recurrent wheezing and physician-diagnosed recurrent wheezing, compared with the combined non-prophylaxed group.

About Synagis

Synagis is the only monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to help prevent an infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.

Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries.

The safety and efficacy of Synagis were established in infants with bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to commencement of the RSV season, which usually starts in the fall and runs through the spring. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.

Abbott has exclusive rights to Synagis in markets outside the United Stat
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