Thursday, 24 December 2009
AstraZeneca today announced that MedImmune, its biologics unit, has filed its formal regulatory reply to a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). MedImmune received the CRL asking for additional information regarding motavizumab on 25 November 2008, and the company has been in ongoing discussions with FDA reviewers since then to complete and file its CRL reply.
The CRL is in connection with the Biologics License Application (BLA) for motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants, which was submitted on 30 January 2008. Motavizumab is an investigational monoclonal antibody (MAb) with enhanced activity against RSV compared to Synagis (palivizumab).
MedImmune was not required to conduct additional clinical trials in responding to the CRL. MedImmune will continue discussions with the FDA reviewers as needed throughout the remainder of the registration process.
给编辑的注释：
关于阿斯利康欧洲杯微信买球
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:www.vivelima.com
关于Medimmune
MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website atwww.medimmune.com.
联系人：
Media Enquiries:
Neil McCrae +44 207 304 5045 (24 hours)
Chris Sampson +44 207 304 5130 (24 hours)
Sarah Lindgreen +44 207 304 5033 (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