AstraZeneca and MedImmune have announced that the European Medicines Agency (EMA) has granted access to its PRIME (PRIority MEdicines) scheme for MEDI8897 and in addition, the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897.
MED 18897 is 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 PRIME initiative
The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimize 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.
“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 optimize our development plan and help us bring MEDI8897 to patients as quickly as possible,” says Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, AstraZeneca.
The first EMA PRIME eligibility
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.
A BTD
A BTD is 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.
The BTD 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.
Photo of Mene Pangalos: AstraZeneca
