New Pharmaco-Economic Data At AAP Regarding Infants At High Risk For RSV Presented By MedImmune

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Pediatrics / Children's Health;  Clinical Trials / Drug Trials
Article Date: 30 Oct 2007 - 7:00 PST


MedImmune has announced results from a recent economic analysis of Synagis® (palivizumab), a monoclonal antibody (MAb) that is the standard of care for prevention of severe lower respiratory tract infection due to respiratory syncytial virus (RSV) in high-risk infants. Released at the American Academy of Pediatrics (AAP) 2007 National Conference & Exhibition, the analysis evaluated the costs of providing Synagis to premature infants, as well as the potential health benefits and cost savings that could occur from lower rates of severe RSV infections.

RSV can cause severe lower respiratory tract infections in preterm infants. However, recent data have suggested that RSV infection early in an infant's life may cause subsequent chronic respiratory complications such as persistent wheezing.

Dr. Mark Polak, a neonatologist and professor of pediatrics from the West Virginia University School of Medicine and lead author of the economic analysis, noted, "We factored in the potential costs of possible future complications and the quality of life associated with persistent wheezing and, based on these assumptions, our study found that preventing RSV early in life makes economic sense."

The authors noted that more evidence is needed to substantiate the linkage between Synagis and subsequent reductions in persistent wheezing.

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MedImmune's Commitment to RSV Prevention

MedImmune is a world leader in the development of innovative therapeutic biologic products to prevent RSV disease. In 1996, MedImmune launched the first anti-RSV drug, RespiGam® (respiratory syncytial virus immune globulin intravenous (human) (RSV-IGIV)), which was a polyclonal antibody administered via four-hour intravenous infusion. In 1998, MedImmune introduced Synagis, which was a significant product improvement as a monthly intramuscular injection for the prevention of severe RSV, as well as being the first MAb to receive U.S. Food and Drug Administration (FDA) approval for an infectious disease. MedImmune continues to reinforce its commitment to developing anti-RSV products with the ongoing development of its next potential anti-RSV antibody, motavizumab, for which the company is planning to submit a Biologic License Application around the beginning of 2008. MedImmune is also developing a small-molecule product candidate to prevent RSV as well as a vaccine against RSV, both of which are in Phase 1 clinical trials.

About RSV

Each year, up to 125,000 infants in the United States are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in U.S. infants. 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.

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. 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

Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com/.

Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis. 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.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com/.

Source: Tor Constantino
Edelman Public Relations

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