AstraZeneca’s global biologics R&D arm, MedImmune, has received Fast Track designation from the FDA for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with type A strain influenza. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.
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. A recently completed phase I study in healthy adult subjects demonstrated that MEDI8852 had an acceptable safety and pharmacokinetics profile, which supported continued development in patients with influenza.
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. 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.”
MedImmune has received Fast Track designation for the majority of its current clinical programs in infectious disease. In April 2015, the FDA granted fast track status to MEDI8897, a novel monoclonal antibody for the prevention of serious respiratory disease caused by respiratory syncytial virus (RSV) in infants. Fast track designation was also granted in September 2014 to MEDI3902, for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious disease in hospitalized patients. In late 2014, MEDI4893 was granted fast track status for the prevention of pneumonia caused by the bacterium Staphylococcus aureus (S. aureus) in intensive care unit patients, which is also often multidrug resistant.
Influenza virus infection remains a serious threat to global health and world economy. Annual epidemics result in a substantial number of hospitalizations, with an estimated 3-5 million cases of severe disease and 250,000 to 500,000 deaths globally, and higher mortality rates are possible during pandemics. Given the emergence of drug-resistance, the short treatment window of antivirals and the lack of universal or broadly cross-protective vaccines, there is a significant unmet medical need for new therapeutic agents that can effectively treat influenza infection.
