FDA Grants Fast Track Status to AstraZeneca’s mAb for Certain Types of InfluenzaBy
AstraZeneca and its global biologics research and development arm, MedImmune, have received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with Type A strain influenza. The FDA's Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.
MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains.
MEDI8852 is an investigational human IgG1 kappa monoclonal antibody (mAb) administered via infusion. The precursor to MEDI8852 was isolated from human memory B cells by Humabs BioMed, and further optimized for enhanced neutralization activity at MedImmune. MEDI8852 binds to a region within the stalk of the hemagglutinin protein that is highly conserved among all influenza A subtypes. MEDI8852 is being developed as a treatment for patients hospitalized with influenza caused by Type A strains in conjunction with local standard of care. While MEDI8852 is being developed as a treatment for seasonal influenza disease, it is anticipated that it could also be used in the pandemic setting.
MedImmune has received Fast Track designation for the majority of its current clinical programmes in Infectious Disease. In April 2015, the FDA granted fast track status to MEDI8897, a novel monoclonal antibody for the prevention of serious respiratory disease caused by respiratory syncytial virus (RSV) in infants. Fast track designation was also granted in September 2014 to MEDI3902, for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious disease in hospitalized patients. In late 2014, MEDI4893 was granted fast track status for the prevention of pneumonia caused by the bacterium Staphylococcus aureus (S. aureus) in intensive care unit patients, which is also often multidrug resistant.