June 25, 2010 — AstraZeneca today announced that MedImmune, its wholly owned biologics unit, received notice that the U.S. Food and Drug Administration (FDA) has reset the decision date for its review of motavizumab to 27 August 2010.
Motavizumab is an investigational monoclonal antibody (MAb) being considered to help prevent serious respiratory syncytial virus (RSV) disease. MedImmune filed the original Biologics License Application (BLA) on 30 January 2008, and received a Complete Response Letter (CRL) in November 2008. It filed the response to the CRL in December 2009. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory Committee on 2 June 2010.
Motavizumab is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease.
MedImmune, the worldwide biologics unit for AstraZeneca, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland.
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