Motavizumab should not be licensed for marketing: FDA Antiviral Drugs Advisory Committee

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."