AstraZeneca announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the US Food and Drug Administration (FDA).
Based on the preliminary assessment of the CRL, it contains the following requirements that the company should address to advance the motavizumab registration: The FDA has requested evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population(s) 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 the FDA as well as make a decision regarding next steps in due course.
Motavizumab is an investigational monoclonal antibody (MAb) being considered to help prevent serious respiratory syncytial virus (RSV) disease. MedImmune filed the original Biologics License Application (BLA) on 30 January 2008, and received a (CRL) in November 2008. It filed the response to the CRL in December 2009. Motavizumab was reviewed by the FDA's Antiviral Drugs Advisory Committee on 2 June 2010.
As previously disclosed, the Group holds intangible assets of $445 million relating specifically to motavizumab, which may be subject to impairment following completion of the Group's analysis of the CRL. Any impairment would be excluded from Core earnings and, as such, the company's Core earnings per share guidance for 2010 remains unchanged at $6.35-$6.65.
MedImmune, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.