PhaseBio Receives FDA Breakthrough Therapy Designation
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment (Fab fragment). It is designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgical situations.
Ticagrelor is marketed by AstraZeneca as Brilinta. It is prescribed to lower the risk of another heart attack or dying from a heart attack or stroke. But, because it is a blood thinner, it can lead to serious bleeding and death under certain circumstances. PB2452 is a way to counteract the effects of Brilinta under emergency situations.
Breakthrough Therapy designation expedites the development and review of promising new drugs for serious or life-threatening conditions, particularly if early data shows it offers a significant improvement over existing therapies.
The Breakthrough Therapy designation was supported by Phase I clinical trial data where PB2452 showed immediate and sustained reversal of ticagrelor’s effects. The data were published in the New England Journal of Medicine and presented at the American College of Cardiology’s 68th Scientific Session.
[Originally posted by BioSpace — April 9, 2019]