Progress for AstraZeneca and MedImmune on drug for children infected with respiratory virus
AstraZeneca and MedImmune have welcomed progress in the US and Europe for their antibody therapy to treat infections in infants caused by respiratory syncytial virus (RSV).
Some 90 per cent of children are infected with RSV in the first two years of their life and 40 per cent of those will experience a lower respiratory tract infection with the initial episode.
Now the US Food and Drug Administration has granted Breakthrough Therapy Designation for MEDI8897, an extended half-life respiratory syncytial virus F monoclonal antibody.
Meanwhile, the European Medicines Agency has granted access to its PRIME PRIority MEdicines) scheme for the drug. The scheme offers early, proactive and enhanced support to developers of promising medicines for high unmet needs. This is the first EMA PRIME eligibility that AstraZeneca has received since the programme’s initiation in 2016.
Mene Pangalos, executive vice-president, R&D biopharmaceuticals at the Cambridge-based company, 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.”