Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.MedImmune, a subsidiary of AstraZeneca, has reported that the FDA’s 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.
Subscribe to our email newsletter
Motavizumab (proposed INN, trade name Numax) is a humanised monoclonal antibody. It is being investigated by MedImmune for the prevention of respiratory syncytial virus infection in high-risk infants.
The committee’s recommendation is expected to be considered by FDA reviewers in their evaluation of the biologics license application (BLA) for Motavizumab.
Genevieve Losonsky, vice president of clinical development for infectious disease at MedImmune, said: “We continue to believe Motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness.
“We thank the committee for the thoroughness of its review. 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.”