FDA backs AZ’s new antibody to fight respiratory illness
AstraZeneca and its biologics R & D arm, MedImmune, have won a key approval in the US for a nextgen respiratory disease solution caused by Respiratory Syncytial Virus. Infants are considered to be particularly vulnerable.
The Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) for MEDI8897, a monoclonal antibody which is being developed for the prevention of lower respiratory tract infection.
A BTD is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.
MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the FDA in March 2015.
AstraZeneca’s Mene Pangalos, executive VP R & D BioPharmaceuticals, said: “MEDI8897 is our next-generation preventive medicine for respiratory syncytial virus, which has the potential to address an important unmet need for infants, families and caregivers.
“The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible.”
The BTD is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint.