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April 9, 2015

MedImmune receives FDA fast-track designation to develop MEDI8897 for LRTI

AstraZeneca’s MedImmune has obtained fast-track designation from the US Food and Drug Administration (FDA) to develop MEDI8897 for prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

RSV

AstraZeneca’s MedImmune has obtained fast-track designation from the US Food and Drug Administration (FDA) to develop MEDI8897 for prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

MEDI8897 is an investigational recombinant human immunoglobulin G1 kappa (IgG1?) monoclonal antibody (mAb) with an extended half-life, which neutralises RSV by binding the prefusion conformation of the RSV fusion (F) protein expressed on virions and infected cells.

MedImmune infectious diseases and vaccines innovative medicines unit head and R&D senior vice-president Steve Projan said: "While the burden and seriousness of RSV disease has kept it a global priority for vaccine development for more than 50 years, it is well-recognised that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide."

"It is well-recognised that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide."

Under the development programme, the company is using its proprietary technology to enhance the half-life of MEDI8897, allowing to provide only one dose for the entire RSV season.

MEDI8897 demonstrated potent antiviral activity against a diverse panel of RSV A and B clinical isolates in preclinical in-vivo and in-vitro studies, showing broad-spectrum antiviral activity against RSV.

It is currently being investigated in a Phase I study to assess the safety, tolerability and pharmacokinetics of the antibody in healthy adults.

A separate Phase Ib/IIa study is being initiated to examine MEDI8897 in healthy preterm infants, based upon analysis of interim data from this study.

The FDA also granted fast-track status to MEDI3902 in September 2014 to study it for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P aeruginosa) in late-2014 to research it for the prevention of nosocomial pneumonia caused by the bacterium Staphylococcus aureus (S aureus).


Image: An X-ray of a child with RSV showing the typical bilateral perihilar fullness. Photo: courtesy of James Heilman, MD.

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