AstraZeneca Biologics Division, MedImmune, Submits Biologics License Application to FDA for motavizumab
AstraZeneca PLC announced today that its biologics division, MedImmune, had submitted a Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology.
“We expect that this submission will lead to the first new medicine delivered by MedImmune since we acquired the company in June 2007 and one of three new filings that we plan to make this year. MedImmune has a well-established reputation in the prevention of RSV through its existing product, Synagis. Motavizumab offers the opportunity to build on this knowledge and improve treatment for a young and vulnerable patient population,” said David Brennan, Chief Executive Officer, AstraZeneca.
Jamie Lacey, (MedImmune) +1 301 398 4035
Steve Brown, +44 207 304 5033 (24 hours)
Edel McCaffrey, +44 207 304 5034 (24 hours)
Jonathan Hunt, +44 207 304 5087
Ed Seage, +1 302 886 4065
Karl Hard, +44 207 304 5322
Jorgen Winroth, +1 212 579 0506
Peter Vozzo, (MedImmune) +1 301 398 4358
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