Posted by Michael Wonder on 05 Feb 2019
US FDA grants breakthrough therapy designation for potential next-generation RSV medicine MEDI8897
5 February 2019 - Designation based on positive primary analysis of the Phase IIb trial that demonstrated the safety and efficacy of MEDI8897
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US FDA has granted breakthrough therapy designation for MEDI8897, an extended half-life respiratory syncytial virus F monoclonal antibody being developed for the prevention of lower respiratory tract infection caused by RSV.
MEDI8897 is being developed in partnership with Sanofi Pasteur and received fast track designation from the US FDA in March 2015.
