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MedImmune gets FDA fast track status for MEDI8897 to prevent LRTI caused by RSV in infants

AstraZeneca's global biologics R&D arm MedImmune has received fast track designation from the US Food and Drug Administration (FDA) to develop MEDI8897, an investigational recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb).

This monoclonal antibody is being examined for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

The company currently markets a monoclonal antibody for the treatment of severe RSV disease.

MEDI8897 is being developed for the passive immunization of all infants, term and preterm, as part of the company’s aim to increase the number of infants who are protected from LRTI caused by RSV.

MedImmune R&D senior vice-president and Infectious Diseases & Vaccines Innovative Medicines Unit head 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 recognized that a significant unmet medical need continues to exist for the prevention of RSV in all infants worldwide.

"We are working with a sense of urgency to develop a next-generation RSV mAb that we believe has the potential to benefit hundreds of thousands more infants, both in the US and around the world. If successful, the fast track designation will enable us to more quickly deliver a preventative solution."

Under the 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.

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

Currently, MEDI8897 is being investigated in a Phase I trial designed to evaluate the safety, tolerability and pharmacokinetics of the antibody in healthy adults.

The company said that based upon analysis of interim data from the trial, a separate Phase Ib/IIa trial has been initiated to examine MEDI8897 in healthy preterm infants.