FDA resets its decision date

RNS Number : 2372O

AstraZeneca PLC

25 June 2010

 



FDA resets its decision date FOR MOTAVIZUMAB

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.

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About Motavizumab

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.  

About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com.

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25 June 2010

 

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