US FDA fast-tracks MedImmune's RSV candidate
MedImmune, the global biologics R&D unit of Anglo-Swedish pharma major AstraZeneca (LSE: AZN), has received fast track designation from the US Food and Drug Administration for the development of MEDI8897.
This high-potency, extended half-life monoclonal antibody (MAb) is being investigated for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children. The FDA’s fast track program is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
MedImmune previously discovered, developed and currently markets a monoclonal antibody for severe RSV disease. The company aims to increase the number of infants who are protected from LRTI caused by RSV through its development of MEDI8897 for the passive immunization of all infants, term and preterm. As part of its development program, MedImmune is applying its proprietary technology to increase the half-life of MEDI8897, so that only one dose will be needed for the entire RSV season.
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