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GAITHERSBURG, Md. AstraZeneca's biologics unit has received a second complete response letter from the Food and Drug Administration regarding an investigational drug designed to treat respiratory syncytial virus disease.
In the second CRL, the FDA requested that MedImmune complete an additional clinical trial that supports a satisfactory risk/benefit profile to advance the registration of motavizumab, its investigational monoclonal antibody.
MedImmune filed the original biologics license application in January 2008 and received its first complete response letter in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory committee on June 2 of this year.