Study Shows Physician Judgment is Important in Reducing Rate of RSV-Related Hospitalizations Among High-Risk Infants

Tuesday, May 6, 2008 General News
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HONOLULU, May 5 MedImmune announced today that the companypresented results from a retrospective chart review that evaluated the use ofSynagis(R) (palivizumab) as a preventive measure against respiratory syncytialvirus (RSV) disease in high-risk infants. RSV is a leading cause of viralrespiratory infection among preterm infants.

Approximately 4,000 medical records from premature infants born at32-to-35 weeks gestational age were reviewed. Fifty percent of those infantsreceived Synagis. RSV prophylaxis was requested, but not administered inabout one quarter of these infants. This group was found to have an RSVhospitalization rate of 8.3 percent, which was almost three times the rate ofRSV hospitalization among those infants whose physicians did not request RSVprophylaxis (2.9 percent).

"These data support our position that pediatricians should have the finalsay in the diagnosis and care of their high-risk patients," said JessieGroothuis, M.D., lead author of the study and MedImmune vice president,medical and scientific affairs, infectious disease. "Our findings indicatethat after nearly 10 years of use of Synagis, the clinical judgment andexperience of physicians serve to identify infants at high risk of RSVhospitalization, and should be relied upon to ensure patients get propercare."

This retrospective chart review, conducted in 10 geographic regions acrossthe United States, included 376 physicians from 2005 to 2006. Data werepresented at a poster session at the Pediatric Academic Societies (PAS) AnnualMeeting being held this week in Honolulu, HI.

About Synagis

Synagis (palivizumab) is indicated for the prevention of serious lunginfections caused by respiratory syncytial virus (RSV) in children at highrisk of RSV disease. Synagis is given as a shot, usually in the thigh muscle,each month during the RSV season. The first dose of Synagis should be givenbefore RSV season begins. Children who develop an RSV infection whilereceiving Synagis should continue the monthly dosing schedule throughout theseason. Synagis has been used in more than one million children in the U.S.since its introduction in 1998.

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

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

Please see complete prescribing information at www.synagis.com.

About MedImmune

MedImmune strives to provide better medicines to patients, new medicaloptions for physicians and rewarding careers to employees. Dedicated toadvancing science and medicine to help people live better lives, the companyis focused on infection, oncology, respiratory disease and inflammation,cardiovascular/gastrointestinal disease, and neuroscience. With approximately3,000 employees worldwide and headquarters in Maryland, MedImmune is whollyowned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visitMedImmune's website at www.medimmune.com.

SOURCE MedImmune


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