FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for 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.
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.
Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: “MEDI8897 is our next-generation preventive medicine for respiratory syncytial virus, which has the potential to address an important unmet need for infants, families and caregivers. The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible.”
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.