The FDA has asked AstraZeneca's (NYSE: AZN) MedImmune for more data on motavizumab, a monoclonal antibody being considered to help prevent serious respiratory syncytial virus. The disease is a major cause of lower respiratory tract infection and hospital visits in infants and children. In the complete response letter, the agency said it would need data from an additional trial of the drug to support a satisfactory risk/benefit profile for which the prophylaxis indication is being requested.
"The company continues to believe in the clinical benefit of motavizumab, and it will conduct a complete review of the CRL, continue ongoing constructive dialogue with FDA as well as make a decision regarding next steps in due course," MedImmune noted in a statement.
The FDA previously moved its decision date on the drug from from June 24 to Aug. 27. That adjustment followed a 14 to 3 vote by an FDA expert panel, which raised a red flag on data linking motavizumab to a higher number of allergic reactions. The panel also wondered whether motavizumab is more more effective than Synagis--which loses patent protection in 2015.
- check out MedImmune's release
- see the report from Reuters