MedImmune Inc. announced late Wednesday that the FDA haspostponed its advisory committee review of Respivir, apolyclonal antibody product for treating respiratory syncytialvirus (RSV) infections in children.
The FDA's Blood Products Advisory Committee was scheduledto review MedImmune's product license application (PLA) onthe prophylactic therapy on Sept. 23. FDA has not set a newdate.
"The FDA said that it needs more time to complete its analysis(of the data) before it goes to the advisory committee,"explained David Mott, MedImmune's vice president ofdevelopment and planning.
MedImmune (NASDAQ:MEDI) submitted its PLA on Respivir toFDA last Dec. 22. Mott said that MedImmune was surprised athow rapidly Respivir came up for review. "FDA has done abang-up job at moving quickly with its review (of PLAs andnew drug applications, or NDAs)," said Mott.
One reason for FDA's speed may have been the seasonal natureof the disease, which prevails from November until April.Another could be the fact that RSV is the leading cause ofpneumonia and bronchiolitis in infants, and causes more than91,000 hospitalizations and 4,500 deaths annually in the U.S.
MedImmune of Gaithersburg, Md., announced the results of itsclinical study on Respivir at the Sixth International Conferenceon Antiviral Research in late April and at the Society forPediatric Research annual meeting in early May.
In a three-year pivotal clinical trial of 249 children, theantibody-based product significantly reduced the incidence andseverity of RSV disease in high-risk children. The study wasconducted in premature infants, children with chronic lungdisease and children with congenital heart disease. Thechildren received monthly doses of Respivir throughout thevirus season. The high-risk group showed a 63 percentreduction in hospitalizations, a 72 percent reduction inmoderate to severe RSV disease and a 97 percent reduction inintensive-care unit days.
No approved product to prevent RSV disease currently exists inthe U.S.
-- Jennifer Van Brunt Senior Editor
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