Compliance Management / Large Molecule

AstraZeneca Flu Drug Wins FDA Fast Track Designation

Mar 08, 2016

AstraZeneca reported its biologics R&D arm, MedImmune, has received Fast Track designation from the U.S. Food and Drug Administration for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with Type A strain influenza.

MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to investigate the safety and efficacy of a single intravenous dose in combination with oseltamivir, and as a monotherapy in adult patients with confirmed acute, uncomplicated influenza caused by Type A strains.

Steve Projan, Senior Vice President, R&D and Infectious Diseases & Vaccines iMED Head, MedImmune, said: “We are pleased that the FDA has granted Fast Track designation for MEDI8852 as it recognizes the importance of accelerating the development of new medicines for the prevention and treatment of challenging infectious diseases.”