NOTICE: Advisory Committee Briefing Materials for Motavizumab BLA Available on US FDA Web Site

Friday, 28 May 2010

The US Food and Drug Administration (FDA) today posted briefing materials in advance of 2 June 2010 Antiviral Drugs Advisory Committee to discuss the approval of motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.

The briefing materials can be found on the FDA web site:

View briefing material

In December 2009, AstraZeneca announced that MedImmune, its biologics unit, had 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.

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.  It is currently under review at the U.S. FDA.


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