The Gaithersburg, Maryland-based MedImmune, AstraZeneca's wholly owned biologics business, has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) asking for additional information on motavizumab, an investigational monoclonal antibody (MAb).
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 January 30, 2008.
The company is confident that it can respond to the outstanding questions and it 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 the application in the first half of 2009.
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.