MedImmune, the worldwide biologics research and development branch of AstraZeneca, recently gained Fast Track designation for its MEDI18852, an investigational human monoclonal antibody (mAb), from the U.S. Food and Drug Administration (FDA).
The treatment is designed specifically for patients who have Type A strain influenza and receive hospitalization for their illness.
With this designation, MedImmune will be able to accelerate its development and review of MEDI18852. It is currently involved in a Phase Ib/IIa clinical trial that will determine the effectiveness and safety of using one intravenous dose along with oseltamivir. This will be used for a monotherapy among adult patients with Type A influenza strain infections.
The latest data from the company’s Phase I study involved healthy adult subjects. When they received MEDI8852, subjects showed proper pharmacokinetics and safety profiles.
“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,” Steve Projan, senior vice president of infectious diseases and vaccines, MedImmune, said. “This is the fourth such designation that MedImmune has received for potential medicines in infectious diseases since 2014, a testament to our commitment to meeting unmet medical need.”
