MedImmune Inc. announced Tuesday that a recent clinicalstudy showed that its polyclonal antibody against respiratorysyncytial virus effectively prevents RSV disease in high-riskchildren.
RSV is the leading cause of pneumonia and bronchiolitis ininfants, and causes more than 91,000 hospitalizations and4,500 deaths each year in the U.S.
In a three-year pivotal clinical trial of 249 children,MedImmune's Respivir significantly reduced the incidence andseverity of RSV disease in high-risk children, according to apresentation at the Sixth International Conference on AntiviralResearch in Venice, Italy, on Tuesday by Jessie Groothuis ofThe Children's Hospital, University of Colorado Health SciencesCenter.
Groothuis led the study by 17 physicians at five U.S. centers inpremature infants, children with chronic lung disease andchildren with congenital heart disease.
Monthly doses of Respivir were injected intravenously duringthe virus season, November through April. Eighty-one childrenreceived a high dose of 750 mg/kg, 79 received a low dose of150 mg/kg, and 89 children were enrolled as a control group.
The high-risk group showed a 63 percent reduction inhospitalizations, a 72 percent reduction in moderate to severeRSV disease and a 97 percent reduction in intensive care unitdays.
Adverse reactions were infrequent and usually easily reversed,Groothuis said. Reactions included mild fluid overload, milddecreased oxygen saturations and transient fevers. In the high-risk infant group, three deaths occurred in each treatmentgroup and none in the control group, but none of the deathswere attributed to treatment. As children were followed over asecond RSV season, no long-term safety concerns wereobserved.
MedImmune filed a product licensing application (PLA) forRespivir with FDA in December 1992. There is no currentlyapproved product to prevent RSV disease in the U.S.
Groothuis plans to report results of the study May 6 at theSociety for Pediatric Research annual meeting in Washington,D.C.
MedImmune's stock (NASDAQ:MEDI) closed at $14.75 a shareon Tuesday, off 25 cents.
-- Nancy Garcia Associate Editor
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