AstraZeneca’s MEDI8897 has been granted access to both the European Medicines Agency (EMA) PRIME (PRIority MEdicines) scheme, as well as the US Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) for the treatment respiratory syncytial virus (RSV).
The decisions come on the back of positive primary analysis of the phase IIb trial to evaluate the safety and efficacy of MEDI8897, an extended half-life RSV F monoclonal antibody (mAb) developed for the prevention of lower respiratory tract infection (LRTI), caused by RSV.
The PRIME scheme launched by the EMA in 2016, offers Pharma companies early and enhanced support in optimising medicines as well as offering accelerated evaluation, so medicines come to market and ultimately reach patients much quicker.
The phase IIb trial found that the drug met its primary endpoint of a significant reduction in incidences of medical-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV for 150 days in health preterm infants.
MEDI8897 is being developed in partnership with Sanofi Pasteur and received its Fast Track designation by the FDA in March 2015.