AstraZeneca withdraws BLA for motavizumab for serious respiratory syncytial virus (RSV)

AstraZeneca announced it has discontinued further development of motavizumab for the prophylaxis of serious respiratory syncytial virus (RSV) disease.  It has requested withdrawal of the Biological License Application (BLA) pending at the FDA. MedImmune (AstraZeneca's biologics unit) filed the original BLA on January 30, 2008, and received its first complete response letter (CRL) in November 2008. Motavizumab was reviewed by the FDA's Antiviral Drugs Advisory Committee on June 2, 2010, and the FDA issued a second CRL requesting additional clinical data in August 2010. Subsequently MedImmune has decided to discontinue certain motavizumab development paths and withdraw the prophylaxis BLA from the FDA. However, motavizumab remains in development for other RSV treatment.

Motavizumab is an investigational monoclonal antibody that was being considered to help prevent RSV disease.

For more information call (800) 236-9933 or visit www.astrazeneca.com