FDA grants fast track status to MedImmune’s MEDI3902 for prevention of P. aeruginosa

P. aeruginosa is a highly drug-resistant bacterial pathogen that causes serious disease in hospitalized patients.

MEDI3902 is a new mAb engineered to combine three distinct mechanisms of action for disarming and clearing P. Aeruginosa and it is currently entering Phase I clinical trials.

In pre-clinical trials, MEDI3902 was found to produce improved effects for both prevention and treatment of the problematic bacterial infection in multiple animal models.

The company said that prophylactic use of MEDI3902 represents a potentially new therapeutic approach for controlling pneumonia in hospitalised patients.

MedImmune senior vice-president R&D and Infectious Diseases & Vaccines iMED head Steve Projan said: "We are pleased that the FDA has granted Fast Track designation for MEDI3902, recognising the unique science behind this investigational monoclonal antibody and the importance of accelerating development of new medicines that may prevent serious bacterial infections, such as nosocomial pneumonia, rather than solely relying on antibiotics to treat them."

MedImmune, the global biologics research and development arm of AstraZeneca, is currently exploring ways of using biologics to help prevent and treat challenging infectious diseases, including P. aeruginosa.