Astra submits respiratory treatment response to FDA

24th Dec 2009 07:11

Drug maker AstraZeneca said its biologics unit, Medimmune, has filed a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) in respect of its Biologics Licence Application (BLA) for motavizumab.The FDA had asked for additional information regarding motavizumab on 25 November 2008, since when discussions between Medimmune and the FDA have been taking place over the contents of the CRL.Motavizumab is an investigational monoclonal antibody with enhanced activity against serious respiratory syncytial virus disease compared to Synagis (palivizumab). The treatment is intended for infants at high risk of contracting the disease.The FDA has not required Medimmune to conduct any further tests as a result of the CRL request. Discussions between Medimmune and the FDA will continue throughout the registration process, AstraZeneca said.