
Health Dictionary
Reliable, easy-to-read patient information on common medical conditions — written in plain language, free of jargon, and grounded in current evidence. Browse the most frequent diagnoses, understand what they mean for everyday life, and learn which steps and questions help you have a focused conversation with your doctor.
Motavizumab
Introduction
Overview
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
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.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
