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news.MedImmune has reported that the clinical results of its pivotal multinational, randomised, double-masked trial for Motavizumab have been published in the current issue of the 'Official Journal of the American Academy of Pediatrics.' Motavizumab is an investigational monoclonal antibody (MAb) being evaluated by the FDA for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) among infants at high risk.
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The phase 3, pivotal trial assessed the safety and RSV hospitalisation in 6,635 preterm infants aged six months or younger at enrollment or children aged 24 months or younger with chronic lung disease of prematurity who received either 15mg/kg palivizumab or motavizumab monthly.
Whereas the secondary endpoints included outpatient medically attended lower respiratory tract infections (MALRIs), RSV-specific MALRIs, otitis media, antibiotic use, development of anti-motavizumab antibodies and motavizumab serum concentrations.
In the first head-to-head trial, Motavizumab has demonstrated non-inferiority, but not superiority, to Synagis (palivizumab), meeting the primary endpoint with a 26% relative reduction in RSV hospitalisations versus Synagis due to RSV.
Additonally, Motavizumab has also demonstrated superiority compared to Synagis, with a 50 % relative reduction in RSV lower respiratory tract infections requiring outpatient management, which was one of the secondary endpoints of the trial.
In November 2008, the FDA has issued a complete response letter (CRL) to MedImmune seeking clarification on the Motavizumab Biologic License Application (BLA). MedImmune has filed its response with the FDA in December 2009 and continues in its ongoing dialogue with the agency.