Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: 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.

The phase 3, pivotal trial assessed the safety and RSV hospitalization 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 15 mg/kg palivizumab or motavizumab monthly.  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 this first head-to-head trial, motavizumab demonstrated non-inferiority, but not superiority, to Synagis® (palivizumab), meeting the primary endpoint with a 26 percent relative reduction in RSV hospitalizations versus Synagis (p<0.01 for non-inferiority) due to RSV. Motavizumab also demonstrated superiority compared to Synagis, with a 50 percent relative reduction in RSV lower respiratory tract infections requiring outpatient management>

In November 2008, the FDA issued a complete response letter (CRL) to MedImmune seeking clarification on the motavizumab Biologic License Application (BLA).  MedImmune filed its response with the FDA in December 2009 and continues in its ongoing dialogue with the agency.