The U.S. Food and Drug Administration has granted Fast Track designation to an investigational monoclonal antibody from MedImmune for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
P. aeruginosa is a highly drug-resistant pathogen. In the drug's pre-clinical trials, it was able to both prevent and treat pneumonia caused by P. aeruginosa in animal models. The drug, MEDI3902, could be used as a therapeutic approach to control pneumonia in hospital patients.
The Fast Track program is designed to facilitate the development and expedite the review of new drugs to treat serious conditions and fill an unmet need.
"The Fast Track designation will streamline communications with the FDA throughout the development process on what is a very different approach to the bacterial resistance problem," said Steve Projan, PhD, senior vice president of R&D and infectious diseases & vaccines for MedImmune. "If successful, we hope to bring this important new medicine to patients as quickly as possible."