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AstraZeneca's global biologics research group, MedImmune, received FDA Fast Track designation for MEDI3902, for the prevention of nosocomial pneumonia.
MedImmune, the global biologics research and development sector of AstraZeneca, announced on Sept. 23, 2014 that it received Fast Track designation from FDA for its investigational monoclonal antibody (mAb), MEDI3902, for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa). P. aeruginosa is a highly drug-resistant bacterial pathogen that can cause serious disease in hospitalized patients.
MEDI3902, a mAb that combines three distinct mechanisms of action for disarming and clearing P. aeruginosa, is entering Phase I clinical trials. In preclinical trials, MEDI3902 had positive effects for both prevention and treatment of bacterial infection in multiple animal subjects. Studies demonstrated that engineered mAbsmay protect against infection, work with marginally active antibiotics against drug-resistant strains, and prevent coinfections with multiple bacteria.