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news.MedImmune, a wholly owned biologics unit of AstraZeneca, has received notice stating that the FDA has reset the decision date for its review of Motavizumab to August 27, 2010.
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Motavizumab is an investigational humanized monoclonal antibody (MAb) being evaluated for its potential to prevent serious lower respiratory tract disease caused by espiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease.
MedImmune has received a complete response letter (CRL) in November 2008 in response to the original biologics license application (BLA) filed by the company on January 30.
MedImmune said that it filed the response to the CRL in December 2009. Motavizumab was reviewed by the FDA’s antiviral drugs advisory Committee on June 2, 2010.
MedImmune has its facilities in Pennsylvania, California, Kentucky, the UK, and the Netherlands.