FDA Grants Fast Track Designation for AstraZeneca's MEDI3902

AstraZeneca announced on September 23, 2014, that its global biologics research and development division, MedImmune, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational monoclonal antibody (mAb) MEDI3902. The drug is intended for the prevention of nosocomial pneumonia, a serious hospital-acquired infection caused by the highly drug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa).

The FDA's Fast Track program is designed to expedite the development and review of drugs that treat serious conditions and fulfill an unmet medical need. MEDI3902 is a novel mAb engineered with three distinct mechanisms of action to disarm and clear P. aeruginosa. Preclinical trials indicated enhanced effects for both prevention and treatment of the bacterial infection in multiple animal models.

MEDI3902 is entering Phase I clinical trials, with an investigation into its prophylactic use as a potential new therapeutic approach for managing pneumonia in hospitalized patients. This approach aims to offer an alternative to relying solely on antibiotics, particularly in light of growing concerns about antimicrobial resistance.

MedImmune is actively exploring biologics for preventing and treating challenging infectious diseases, including P. aeruginosa. The company is also developing other monoclonal antibodies, such as MEDI4893 targeting Staphylococcus aureus. The Fast Track designation is expected to streamline communication with the FDA and accelerate the development pathway for these novel therapies.