LONDON (Reuters) – Britain’s AstraZeneca said a potential medicine to prevent respiratory syncytial virus (RSV) in babies and infants had been granted special status by U.S. and European regulators, designed to speed up the development of novel and better drugs.
The “Breakthrough Therapy” and “Prime” designations in the United States and Europe respectively were based on early results from Phase IIb trials of MEDI8897, AstraZeneca said.
The drug is being developed for use in a broader infant population than the standard of care for RSV prevention, Synagis, which needs monthly injections and is therefore only approved in Europe for high-risk infants.
MEDI8897, which is being developed in partnership with Sanofi Pasteur, only requires one dose during a typical five month RSV season, AstraZeneca said.
RSV is the most common cause of lower respiratory tract infection in infants and children worldwide, and 90 percent of children are infected with RSV in the first two years of life.
Reporting by Paul Sandle, editing by Louise Heavens