MedImmune Receives Fast Track Designation From FDA For Development Of MEDI3902 For Prevention Of Nosocomial Pneumonia

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LONDON--(BUSINESS WIRE)--AstraZeneca announced today that its global biologics research and development arm, MedImmune, has received fast track designation from the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious disease in hospitalised patients. The FDA’s Fast Track programme is a process designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

MEDI3902, currently entering Phase I clinical trials, is a novel mAb engineered to combine three distinct mechanisms of action for disarming and clearing P. aeruginosa. In pre-clinical trials, MEDI3902 was found to produce enhanced effects for both prevention and treatment of the problematic bacterial infection in multiple animal models. Prophylactic use of MEDI3902 will be investigated as a potentially new therapeutic approach for controlling pneumonia in hospitalised patients.

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