motavizumabTreatment for Respiratory Syncytial Virus
FDA Complete Response Letter for Motavizumab
MedImmune Receives FDA Complete Response Letter on Motavizumab
LONDON, Nov. 28, 2008-AstraZeneca today announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab. The CRL is in connection with the Biologics License Application (BLA) for motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease, which was submitted on 30 January 2008. Motavizumab is an investigational monoclonal antibody (MAb).
MedImmune is confident that it can respond to the outstanding questions and, based on the company’s current understanding, does not foresee a need to conduct further trials. MedImmune will continue discussions with the FDA reviewers and, subject to this dialogue, currently expects to resubmit in the first half of 2009.
An update to AstraZeneca investors on progress will be provided when appropriate.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, visit www.astrazeneca.com
MedImmune is a leading innovation-focused biotechnology company whose mission is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/ gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca PLC. For more information, visit MedImmune's website at www.medimmune.com.
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Posted: December 2008
- Medimmune Receives Complete Response Letter On Motavizumab - September 7, 2010
- FDA Advisory Committee Reviews MedImmune's Motavizumab - June 3, 2010
- MedImmune Submits Biologics License Application to FDA for Motavizumab - February 4, 2008