BLA submitted 1/08; original estimated FDA PDUFA date 11/30/08; FDA asking for more info, though no new clinical trials are needed; positive data published in Pediatrics 12/09; MedImmune responds to FDA 12/09; positive phase III data announced 2/10; FDA advisory board scheduled for 6/2/10, but concerned with increased incidence of significant hypersensitivity reactions (5/10); FDA advisory board votes against drug (in a 14-3 decision), noting concerns about side effects, lack of data; PDUFA date 6/24/10 (6/10); FDA delays PDUFA date to 8/27/10; FDA requested a new trial in the complete response letter (8/10)
Brand formerly known as Numax Generic motavizumab (Medi-524)
Company name MedImmune, AstraZeneca Product type Speciality
Therapeutic category Respiratory agents Key uses RSV
Other Uses N/A Drug Class monoclonal antibody
Dosage From IM Expected Approval 2011-Q3
FDA Filing 1/08 Last Update date August 30,2010
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