AstraZeneca: FDA Resets Review Date For Motavizumab To Aug 27

25th Jun 2010 07:11

LONDON (Dow Jones)--AstraZeneca PLC (AZN.LN), a global biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines, said Friday its biologics unit MedImmune received notice that the U.S. Food and Drug Administration has reset the decision date for its review of motavizumab to Aug. 27. MAIN FACTS: -Motavizumab is an investigational monoclonal antibody being considered to help prevent serious respiratory syncytial virus disease. -MedImmune filed the original Biologics License Application on Jan. 30, 2008, and received a Complete Response Letter in November 2008. -MedImmune filed the response to the complete response letter in December 2009; Motavizumab was reviewed by U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee on June 2. -Shares of AstraZeneca on Thursday closed at 2997 pence, valuing the company at GBP4.32 billion. --By Tapan Panchal, Dow Jones Newswires. Tel +44(0)207-842 9448, [email protected] (END) Dow Jones Newswires June 25, 2010 02:11 ET (06:11 GMT)