MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today highlighted real-world evidence presented over the weekend at The American College of Cardiology’s 70th Annual Scientific Session.
The poster presentation summarized an analysis of the IBM® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. All patients were required to present ≥1 year of continuous insurance coverage prior to initiating their therapy, and outcomes were measured while patients remained on therapy. Bleeding events were identified utilizing diagnosis codes on emergency room (ER) or inpatient insurance claims. All surgical and invasive diagnostic procedures were classified as urgent if filed as an ER claim or as an inpatient claim with ambulance service. All other surgical and invasive diagnostic procedures were classified as non-urgent. Patient clinical characteristics and demographics were assessed during the baseline period, while outcome measures were assessed during baseline and while patients persistent on their medication.
The results of the analysis demonstrated that patients receiving P2Y12 inhibitors presented a significantly higher burden of baseline comorbid conditions than factor Xa and dabigatran patients. Additionally, the results indicate that bleeding complications and medical procedures are common in patients taking antithrombotic medications. Patients prescribed P2Y12 inhibitors are at least equally as likely as patients using factor Xa inhibitors or dabigatran to experience a bleeding event while persistent on their medication; in some populations, including the Medicare population, P2Y12 inhibitor patients are potentially more likely to experience a bleeding event.
Further, compared to the baseline period, lower rates of urgent and non-urgent procedures were observed across most study populations while patients were persistent on their medication, and may indicate the delay of surgical procedures while taking these medications. This possible delay or avoidance of potentially important surgeries and diagnostic procedures could be driven by the bleeding risk that is associated with all of these medications. Reversal agents that have the potential to mitigate bleeding risk exist for factor Xa inhibitors and dabigatran; however, no such agent currently exists for P2Y12 inhibitors. As patients treated with P2Y12 inhibitors had bleeding and surgery rates that often exceed the rates seen in patients treated with factor Xa inhibitors or dabigatran, PhaseBio and the authors believe this study demonstrates an unmet need for an effective reversal agent for patients prescribed P2Y12 inhibitors.
“This analysis of real-world data highlights that the bleeding risk associated with the P2Y12 inhibitor class of medications is as significant as what we see with the factor Xa class of anticoagulants and dabigatran,” said Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center and Professor of Medicine, Harvard Medical School.
Dr. John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio stated, “With no effective reversal agents currently approved for the P2Y12 inhibitor class of therapies, the extent of the bleeding risk and the subsequent impact on potentially important surgeries and procedures may be underappreciated by cardiologists, surgeons and hospital systems. Seeing this side-by-side comparison of these commonly prescribed classes of therapies, and the patients they are prescribed to, helps to contextualize bleeding risk and the potential benefit of specific reversal agents.”
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