BOSTON, MA, October 11, 2008 – MedImmune announced today it will present four abstracts at the American Academy of Pediatrics (AAP) 2008 National Conference & Exhibition that add to the company's growing body of research into the prevention of respiratory syncytial virus (RSV), a leading cause of viral respiratory infection among preterm infants.
"As we gain data that further demonstrate the burden of RSV disease on preterm babies, the benefits of preventive care become more evident," said Jessie R. Groothius, M.D., vice president, medical and scientific affairs, infectious disease. "We look forward to presenting studies that demonstrate the importance of better identifying and helping to protect preterm infants from of RSV."
MedImmune abstracts to be presented at AAP include:
- Increased Burden from Late-Preterm Births During the First Year of Life – Kimmie K. McLaurin, MS, Saturday, October 11, 2008, from 10:20 - 10:30 a.m.
BACKGROUND: Recent studies suggest that late-preterm infants (between 33 and 35 weeks gestation) are associated with higher medical costs and greater morbidity than full-term infants during and shortly after birth. The effects of late-preterm births beyond this period, however, are unknown. This retrospective cohort study examined the use of medical resources by late-preterm and full-term infants through their first year of life to determine whether differences in medical costs exist.
- A Multi-Center Prospective Study of the Occurrence and Burden of RSV-Associated Illness in the Emergency Department: September-October 2006 and 2007(Poster #927) – Aleta B. Bonner, MD, Friday, October 10, 2008, from 2:45 p.m.
BACKGROUND: According to the Centers for Disease Control and Prevention, RSV activity is considered widespread in a community when greater than 10-percent of all specimens tested by antigen detection for RSV are positive. Traditionally, widespread activity has been defined as occurring between November and March, yet there is growing evidence that RSV outbreaks vary by geographic region and from year to year. This prospective, multi-center surveillance study examined data recorded in the high-volume outpatient setting of hospital emergency departments (in contrast to hospital inpatient data typically used to demonstrate the burden of RSV-associated illness) to analyze RSV activity in September and October over two consecutive years.
- Identifying Residual Risk of Severe RSV Disease Among Unprophylaxed Preterm Infants (Poster #36) Doris Makari, MD, Friday, October 10, 2008, from 6:00 - 6:30 p.m.
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.
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. Synagis is administered by intramuscular injection. 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 States. MedImmune promotes Synagis in the United States.
Important Safety Information
Synagis® (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.
Synagis should not be used in pediatric patients with a history of severe prior reaction to Synagis or its components. Cases of anaphylaxis were reported following re-exposure to Synagis and severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on re-administration of Synagis. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) have been reported.
In clinical trials, the most common adverse events occurring at least 1% more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. There have also been post-marketing reports of injection site reactions.
For full prescribing information for Synagis, see the company's website at: www.medimmune.com/products/synagis/index.asp.
About MedImmune
MedImmune is a leading innovation-focused biotechnology company whose mission it is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/ gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca plc (LSE: AZN.L, NYSE: AZN) . For more information, visit MedImmune's website at www.medimmune.com.