MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, announced that 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 that 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.
The Breakthrough Therapy designation for PB2452 was supported by Phase 1 trial results, in which PB2452 achieved immediate and sustained reversal of ticagrelor’s antiplatelet effects. The results from this trial 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).
“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,” said John Lee, M.D., Chief Medical Officer of PhaseBio. “The results from the Phase 1 clinical trial of PB2452 demonstrated immediate and sustained reversal of the antiplatelet activity of ticagrelor, which could mitigate bleeding concerns associated with use of ticagrelor. Breakthrough Therapy designation supports our goal of making the first approved reversal agent for ticagrelor available to patients and physicians as soon as possible. We look forward to working closely with the FDA throughout the expedited development process.”
Source: PhaseBio Pharmaceuticals, Inc., One Great Valley Parkway, Suite 30, Malvern PA 19355
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