FDA resets review date for Astra drug

25th Jun 2010 07:04

Anglo-Swedish drugs group AstraZeneca said the US Food and Drug Administration (FDA) has reset the decision date for its review of Astra's respiratory disease treatment, motavizumab.The date has been reset to 27 August 2010. Motavizumab was reviewed by the FDA's Antiviral Drugs Advisory Committee on 2 June 2010. External advisers to the FDA panel expressed concerns that motavizumab had been linked in some studies to allergic reactions, plus there were doubts that the drug had any additional benefits over Synagis, an older drug from Medimmune for the same disease,The patent for Synagis is due to expire in 2015. The drug generated $1.08bn in sales last year.Mediommune, Astra's wholly owned subsidiary, filed the original Biologics License Application on 30 January 2008, and received a Complete Response Letter (CRL) in November 2008. It filed the response to the CRL in December 2009.