PhaseBio Pharma granted FDA breakthrough designation for antiplatelet reversal drug
PhaseBio Pharmaceuticals (NASDAQ:PHAS) received the FDA’s breakthrough therapy designation for PB2452, a drug designed to reverse the effects of antiplatelet drug, ticagrelor.
Ticagrelor is administered to patients to reduce the risk of blood clot formation, but also increases the risk of spontaneous bleeding. PB2452, a monoclonal antibody fragment, binds to ticagrelor to reverse its antiplatelet effect.
“Breakthrough therapy designation for PB2452 highlights the critical unmet need for a therapy to reverse the antiplatelet activity of ticagrelor, which is widely prescribed to patients with acute coronary syndrome or a history of heart attack,” John Lee, PhaseBio’s CMO, said in a statement.
The breakthrough designation for PB2452 was supported by PhaseBio’s Phase 1 trial results, which were published in the peer-reviewed New England Journal of Medicine.
The article can be accessed here.