April 30, 2019 — PhaseBio Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PB2452, a novel reversal agent for the antiplatelet drug ticagrelor.
Breakthrough Therapy designation is designed to expedite the development and review of promising new drugs for serious or life-threatening conditions, when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. With all the features of the Fast Track program, Breakthrough Therapy designation also offers companies the opportunity for increased communication with FDA and an organizational commitment involving more intensive guidance from FDA senior managers. Companies may also be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab fragment, designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In Phase 1 clinical and preclinical studies, PB2452 achieved immediate and sustained reversal of ticagrelor’s antiplatelet activity, demonstrating the potential to bring life-saving therapeutic benefit by increasing the safety of ticagrelor and mitigating concerns regarding the bleeding risk associated with antiplatelet drugs. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.
Results from the Phase 1 trial that supported Breakthrough Designation were recently published in the New England Journal of Medicine and presented in a featured clinical research session at the American College of Cardiology’s 68th Scientific Session (ACC.19).
For more information: www.phasebio.com