GAITHERSBURG, Md., June 2 /PRNewswire/ -- MedImmune today announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee has voted 14 to 3 to recommend that motavizumab should not be licensed for marketing regarding the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.
The committee's recommendation will be considered by FDA reviewers in their evaluation of the Biologics License Application (BLA) for motavizumab.
"We continue to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease at MedImmune.
"We thank the committee for the thoroughness of its review today. We will work to address the issues raised by the committee and look forward to continuing to work with the FDA as it completes its review of our application."
Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV.
Motavizumab is an investigational humanized MAb being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. It is currently under review at the U.S. FDA.
MedImmune, the worldwide biologics unit for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune's website at www.medimmune.com.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com
Tor Constantino, 301-398-5801