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Drugs Fut 2008, 33(3): 203
ISSN 0377-8282
Copyright 2008 Clarivate Analytics
CCC: 0377-8282
DOI: 10.1358/dof.2008.033.03.1185672
Madaan, A.
Respiratory syncytial virus (RSV) is a major causative agent of viral bronchiolitis and pneumonia in infants and children. To date, palivizumab (Synagis(R)) is the only monoclonal antibody (MAb) approved for RSV prophylaxis. Palivizumab, however, does not offer complete protection to all recipients and is not effective in inhibiting RSV replication in the upper respiratory passages. Directed attempts to enhance the binding of palivizumab to F protein resulted in the production of motavizumab, a second-generation humanized MAb with vastly superior affinity and potency. In vitro studies have demonstrated that motavizumab binds to RSV F protein 70-fold better than palivizumab, with approximately 20-fold improvement in neutralization of RSV. Motavizumab has been shown to effectively inhibit RSV replication in the upper respiratory tract, with up to a 100-fold reduction in pulmonary RSV titers compared to palivizumab in the cotton rat model. A phase III trial with motavizumab in 6,635 preterm infants at high risk for RSV has been completed with the primary endpoint of establishing noninferiority versus palivizumab. Motavizumab was associated with significantly fewer RSV hospitalizations compared with palivizumab. Additionally, motavizumab demonstrated a statistically significant reduction in the incidence of RSV-specific outpatient lower respiratory infections compared with palivizumab. Drug-related adverse events and drug discontinuations were comparable between the two groups. MedImmune recently submitted a BLA with the FDA for motavizumab.

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