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FDA grants fast track designation to MEDI8897 for prevention of respiratory disease in infants
The FDA granted fast track designation to the investigational monoclonal antibody MEDI8897 for the prevention of lower respiratory tract illness caused by respiratory syncytial virus in infants and young children, the drug’s manufacturer announced.
MEDI8897 (AstraZeneca) is a high-potency, extended half-life monoclonal antibody (mAb) that nullifies RSV by binding to the fusion protein expressed on RSV virions and infected cells.
MEDI8897 is intended for the passive immunization of all infants entering their first RSV season, as well as children with chronic lung disease or congenital heart disease entering their first and second RSV season, for the prevention of lower respiratory tract illness caused by RSV.
“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,” Steve Projan, PhD, senior vice president of research and development and head of infectious diseases and vaccines at MedImmune’s innovative medicines unit, said in the release.
“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 U.S. and around the world. If successful, the fast track designation will enable us to more quickly deliver a preventive solution.”
The FDA based its decision on preclinical studies that indicated MEDI8897 exhibits potent antiviral activity against a diverse panel of RSV A and B clinical isolates, demonstrating broad-spectrum antiviral activity against RSV.
In addition, MEDI8897 is currently being investigated in a phase 1 study to evaluate the safety, tolerability and pharmacokinetics of the antibody in healthy adults. Based upon interim data analysis, a phase 1b/2a study has been opened to examine MEDI8897 in healthy preterm infants.