FDA Resets its Decision Date For Motavizumab

FDA Resets its Decision Date For Motavizumab

Published date :
    25 June 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.

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.

Media Enquiries 
Neil McCrae +44 20 7304 5045  (24 hours)
Chris Sampson +44 20 7304 5130  (24 hours)
Sarah Lindgreen +44 20 7304 5033  (24 hours)
Abigail Baron +44 20 7304 5034  (24 hours)
 
Investor Enquiries UK 
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Karl Hård +44 207 304 5322 mob: +44 7789 654364
Clive Morris +44 207 304 5084 mob: +44 7710 031012
 
Investor Enquiries US  
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043

# # #

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.