Nosocomial Pneumonia Agent Designated Fast Track Status
AstraZeneca's biologics research and development arm, MedImmune, announced that the Food and Drug Administration (FDA) has granted Fast Track status to its investigational monoclonal antibody (mAb), MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
MEDI3902, currently entering Phase 1 clinical trials, is a novel mAb engineered to combine three distinct mechanisms of action for the eradication of P. aeruginosa. In pre-clinical trials, MEDI3902 was found to produce enhanced effects for both prevention and treatment of the bacterial infection in multiple animal models. The prophylactic use of MEDI3902 will be investigated as a potentially new therapeutic approach for controlling pneumonia in hospitalized patients. MedImmune is also studying MEDI4893 in a Phase 2 trial targeting Staphylococcus aureus alpha toxin.
For more information call (800) 237-8898 or visit AstraZeneca.com.