MedImmune presents data at AAP National Conference & Exhibition demonstrating burden of RSV disease

BACKGROUND: The majority of preterm infants are born between 32 and 35 weeks gestation; RSV prophylaxis with Synagis® (palivizumab) has resulted in significant reductions in RSV-associated hospitalizations (RSVH) among this population. The use of Synagis has been restricted, however, due to cost concerns associated with prophylaxis. This retrospective cohort study examined whether risk factors outside of current AAP Red Book guidelines - young chronological age, smoking and overcrowding - could identify a subset population of infants born between 32 and 35 weeks gestation that may be at high risk for RSVH, but not currently recommended for prophylaxis under the AAP guidelines.

• Cost Implications of Expanding Risk Factors for RSV Prophylaxis with Palivizumab for Infants 32-35 Weeks Gestation (Poster #29) – Leonard Krilov, MD, Friday, October 10, 2008 from 6:00 - 6:30 p.m.

BACKGROUND: AAP Red Book guidelines recommend RSV prophylaxis with Synagis for infants born between 32 and 35 weeks gestation with two or more of five risk factors: school-aged siblings, childcare attendance, severe neuromuscular disease, congenital airway abnormality, and exposure to environmental air pollutants (except smoking). Adding select risk factors may help identify a new subset of infants between 32 and 35 weeks gestation at high risk for RSV hospitalization, yet the impact on cost to include those risk factors is not clear. This study examined the cost implications of increasing current risk factor criteria.

Additional information about the 2008 AAP National Conference & Exhibition can be found at http://www.aap.org/nce/.

About RSV

Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients).

About Synagis® (palivizumab)

Synagis is the only monoclonal antibody approved by the 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.