AstraZeneca will incur a financial impairment charge of $455 million before the end of this year as a result of biologics unit MedImmune pulling the BLA for approval of the monoclonal antibody motavizumab in the prophylaxis of serious respiratory syncytial virus (RSV) disease. The firm said it will discontinue further development of motavizumab for the prophylaxis indication but will continue its development for other RSV therapy.
MedImmune, AstraZeneca’s biologics unit, filed the original motavizumab prophylaxis BLA in January 2008 and received its first complete response letter from FDA in November 2008. Motavizumab was reviewed by FDA’s Antiviral Drugs Advisory Committee in June 2010, and the the agency subsequently issued a second CRL requesting additional clinical data. As a result, MedImmune has now decided to discontinue certain motavizumab development paths and withdraw the prophylaxis BLA from the FDA.