Phase 3 data: Anti-RSV antibody to be presented at Pediatric Academic Societies Annual Meeting

Synagis is not currently recommended as a preventive measure among Native American infants at high risk for serious RSV disease.

Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Other side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. Side effects, such as skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.

The pivotal trial for Synagis was called the IMpact trial and comprised a total of 1,502 children who were randomized (500 placebo, 1,002 Synagis) in a double-blind, placebo-controlled protocol where 1,486 children completed the study’s follow-up.

In the IMpact trial, monthly prophylaxis with Synagis via intramuscular injections was associated with a 55-percent reduction in hospitalization as a result of RSV (p=<0.001). Reductions were observed in both children with bronchopulmonary dysplasia (38 percent reduction) and premature children without BPD (78 percent reduction). Approximately 50 percent of the children in the analysis had BPD.

For full prescribing information for Synagis, see the company’s website at: www.medimmune.com/products/synagis/index.asp.

About MedImmune

MedImmune strives 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. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at www.medimmune.com.