Reversal agent for antiplatelet effect of P2Y12 inhibitor receives FDA Breakthrough Therapy designation
It was announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for PB2452, a reversal agent for platelet inhibition by the P2Y12 inhibitor ticagrelor. This was supported by results of a phase 1 trial, demonstrating rapid and sustained reversal of ticagrelor-induced platelet inhibition with PB2452.
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 that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
PB2452 is a novel, recombinant, human monoclonal antibody developed to reverse the antiplatelet effect of ticagrelor in patients with major bleeding and in urgent surgery situations. A phase I trial demonstrated that PB2452 can potentially provide life-saving therapeutic benefit by mitigating concerns regarding the bleeding risk associated with antiplatelet drugs. There are currently no approved reversal agents for antiplatelet drugs.