Motavizumab

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

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. As of September 2009, it is undergoing Phase II and III clinical trials.^[1]

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.^[2]

In December 2010, AstraZeneca in a stock market statement stated that it would be writing down $445m (£286m) after discontinuing a key development programme 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.^[3]

References

↑ ClinicalTrials.gov
↑ “FDA Panel Nixes Licensing Request for Motavizumab”. Medscape. 3 June 2010. Retrieved 2014-03-02.
↑ “AstraZeneca halts work on Motavizumab drug”. BBC News. 21 December 2010. Retrieved 2010-12-21.

[1] ClinicalTrials.gov

[2] “FDA Panel Nixes Licensing Request for Motavizumab”. Medscape. 3 June 2010. Retrieved 2014-03-02.

[3] “AstraZeneca halts work on Motavizumab drug”. BBC News. 21 December 2010. Retrieved 2010-12-21.

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