AstraZeneca's (NYSE: AZN) MedImmune unit has received word from the FDA has delayed decision date for its review of motavizumab, an investigational monoclonal antibody being considered to help prevent serious respiratory syncytial virus, from June 24 to Aug. 27.
AZ is hoping that the experimental drug, which had been in MedImmune's pipeline as a successor to Synagis, wins approval. But these hopes may be dashed, especially after a 14 to 3 vote by an FDA expert panel that raised a red flag on data linking motavizumab to a higher number of allergic reactions. The panel members also criticized the lack of proof of improved efficacy over Synagis--which loses patent protection in 2015--and suggested that more clinical trials may be needed to be conducted in children, Pharma Times reports.
MedImmune filed the original biologics license application Jan. 30, 2008, and received a complete response letter a few months later. It filed the response to the CRL in December 2009.
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