WASHINGTON, October 16, 2009 — MedImmune announced today it will present four abstracts at the American Academy of Pediatrics (AAP) 2009 National Conference & Exhibition that add to the company’s growing body of research on the burden of respiratory syncytial virus (RSV) on children, as well as pediatric infectious disease prevention.
“With influenza and RSV becoming more widespread this time of year, it remains important to better understand the impact of infectious diseases on pediatric health and the healthcare system, as well as what we can do to prevent illness,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “The data being presented at the conference build on our extensive foundation of research and help advance innovative solutions for preventing illnesses that negatively impact the health of children.”
MedImmune abstracts to be presented at AAP on RSV include:
- “Late Breaking Trial: A Randomized Controlled Trial of RSV Prophylaxis with Motavizumab vs Palivizumab in Young Children with Hemodynamically Significant Congenital Heart Disease.”
Feltes, T. et al., Oral Presentation; 9:30 AM – Oct 18, 2009; H2019 Section on Cardiology & Cardiac Surgery Program Washington Convention Center, Room 201
BACKGROUND: Congenital heart disease (CHD) patients are at high risk of complications from RSV lower respiratory infection and may benefit from passive immunoprophylaxis. Motavizumab is an investigational RSV-specific monoclonal antibody that is currently being evaluated for its potential to prevent serious disease caused by RSV in high-risk pediatric patients. This randomized, double-blind, active-controlled clinical trial evaluated the safety and tolerability of motavizumab in children with congenital heart disease — a population at high risk for serious RSV disease. Secondary objectives sought to determine the effect of motavizumab on rates of RSV-related hospitalization and RSV-specific lower respiratory tract infections, as well as describe motavizumab’s pharmacokinetics and immune response.
- “Serious Early Childhood Wheezing Following Respiratory Syncytial Virus Lower Respiratory Tract Infection During Infancy Among Preterm Infants”
Romero, JR et al (presenter: Hasan Jafri, MD)[(Friday, October 16, 2009; Room 145 (Washington Convention Center)]
BACKGROUND: Prior studies have suggested that RSV infection is associated with the development of recurrent wheezing in early childhood. However, these studies have had limited sample sizes and lacked laboratory confirmation. This retrospective cohort study sought to determine the relationship between medically attended RSV and recurrent wheezing in the third year of life. Charts of nearly 90,000 infants born at 32 weeks gestation or greater were analyzed for evidence of recurring wheezing and RSV infection, and laboratory testing for RSV was confirmed.
- “Increased Medical Costs and Use within a Year After Respiratory Syncytial Virus Lower Respiratory Tract Infection Among Commercially-Insured Late-Preterm Infants”
Palmer, L et al (presenter: Lisa Palmer, MD) [Friday, October 16, 2009; Room 145 (Washington Convention Center)]
BACKGROUND: RSV is the leading cause of hospitalization for infants up to the age of one, and is responsible for one of every 13 visits to a pediatrician and one of every 38 emergency room trips for children up to the age of five. This burden on the healthcare system has associated costs. This retrospective cohort study evaluated the total healthcare costs and use of services from infants born between 33 — 36 weeks gestation infected with RSV lower respiratory tract infection (LRI). These late-preterm infants were compared with a control group of infants without RSV LRI, all of whom were commercially insured.
MedImmune abstracts to be presented at AAP on influenza include:
- Survey of Physician-Led Influenza Immunization Programs in Schools
Harry F. Hull, M.D., HF Hull & Associates, Oral Presentation: October 19; 11:45-11:55 AM Session: Council on School Health
BACKGROUND: The American Academy of Pediatrics, American Academy of Family Physicians, and the Advisory Committee on Immunization Practices now recommend annual influenza immunizations for all children aged six months to 18 years. School-located immunization programs (SIPs) may offer an efficient, less costly means to reach large numbers of school-aged children. There have been reports of physician-led SIPs conducted independently from public health departments, but little is known about these programs. This study documented the experience of physician-led SIPs for the benefit of other physicians considering organizing SIPs.
Additional information about the 2009 AAP National Conference & Exhibition can be found at http://www.aap.org/nce/.
Palivizumab is a prescription medication that is used to help prevent a
serious lung disease caused by respiratory syncytial virus (RSV) in children at high risk. It is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving palivizumab should continue the monthly dosing schedule throughout the season.
Palivizumab should not be used in patients with a history of a severe allergic reaction to palivizumab or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.
Common side effects may include fever, cold-like symptoms (upper respiratory infection) including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of Synagis.
For full prescribing information for palivizumab (tradename Synagis®), see the company’s website at: http://www.medimmune.com/pdf/products/synagis_pi.pdf
MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, MedImmune aims to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.