MedImmune files Synagis follow-on
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MedImmune filed a BLA for its next-generation respiratory syncytial virus therapy Numax (motavizumab) Jan. 30, setting a Nov. 30 action date for the Synagis (palivizumab) follow-on. Numax met its primary and secondary endpoints of non-inferiority and reducing incidence of RSV-specific lower respiratory infections in approximately 6,600 pediatric patients at high risk for serious RSV-related illness during the two-year, randomized, double-blind, active-controlled Phase III trial against Synagis. The firm will use its existing sales and marketing force in the U.S. and co-market the drug with partner Abbott outside the U.S...