Posted by Michael Wonder on 05 Feb 2019
EMA grants PRIME eligibility for potential next-generation RSV medicine MEDI8897
5 February 2019 - First EMA PRIME eligibility for AstraZeneca.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the EMA has granted access to its PRIME PRIority MEdicines) scheme for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.
This is the first EMA PRIME eligibility that AstraZeneca has received since the programme’s initiation. It is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days after dosing in healthy preterm infants. Full results from the Phase IIb trial will be presented at a forthcoming medical meeting.
