Motavizumab
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Motavizumab (proposed INN, trade name Numax) is a humanized monoclonal antibody. It is being investigated by MedImmune (today a subsidiary of AstraZeneca) for the prevention of respiratory syncytial virus infection in high-risk infants.[1] since September 2009[update]Template:Dated maintenance category (articles)Script error: No such module "Check for unknown parameters"., it was undergoing Phase II and III clinical trials.[2]
In June 2010, the FDA Antiviral Drugs Advisory Committee declined to endorse MedImmune's request for licensure of motavizumab in a 14 to 3 decision. The members of that panel cited several reasons for the decision, and many were concerned that "we're not looking at a product that has evidence of superiority in terms of efficacy" when compared to the already available monoclonal antibody palivizumab.[3]
In December 2010, AstraZeneca in a stock market statement stated that it would be writing down $445m (£286m) after discontinuing a key development program for motavizumab. The company stated that it would no longer develop motavizumab for the prevention of respiratory syncytial virus (RSV), and as a result was withdrawing its licence application to the US Food and Drug Administration. It added that it would continue to develop motavizumab for other treatments of RSV.[4]
References
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- ↑ ClinicalTrials.gov
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External links
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