AstraZeneca’s MEDI8897 has been granted access to both the European Medicines Agency (EMA) PRIME (PRIority MEdicines) scheme, and the US Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD).
The decisions are based on positive primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.
The trial found that the drug 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.
The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimise development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.
A BTD is similarly designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.
MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015.
Mene Pangalos, executive vice president, R&D BioPharmaceuticals, at AZ, said: “We are excited to receive PRIME eligibility for MEDI8897, our next-generation monoclonal antibody targeting respiratory syncytial virus in infants. We will work closely with the European Medicines Agency to optimise our development plan and help us bring MEDI8897 to patients as quickly as possible.”