MEDI8897 receives FDA Fast Track designation for the prevention of respiratory disease caused by RSV in infants

MedImmune has announced that it has received fast track designation from the U.S. Food and Drug Administration (FDA) 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.

RSV is the most prevalent cause of lower respiratory tract infections among infants and young children, resulting in annual epidemics worldwide.  In children younger than one year of age, RSV is the most common cause of bronchiolitis, an inflammation of the small airways in the lung, and pneumonia, an infection of the lungs. There is currently no treatment for RSV once it’s contracted, nor is there an approved preventative therapy for healthy populations.

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 immunisation of all infants, term and preterm.

MedImmune is developing MEDI8897 for the passive immunisation of all infants

“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,” said Steve Projan, PhD, FAAM, Senior Vice President, R&D and Infectious Diseases & Vaccines Innovative Medicines Unit Head, MedImmune. “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 preventative solution.”

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. 

In preclinical in vivo and in vitro studies, MEDI8897 exhibited potent antiviral activity against a diverse panel of RSV A and B clinical isolates, demonstrating broad-spectrum antiviral activity against RSV. 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 analysis of interim data from this study, a separate Phase 1b/2a study has been initiated to examine MEDI8897 in healthy preterm infants. 

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.

For more information about MedImmune, please visit www.medimmune.com.