Brilinta Granted FDA Priority Review for Reduction of Subsequent Stroke in High-Risk Patients When Combined with Aspirin

July 10, 2020 /BioValleyBIOON/ ---AstraZeneca(AstraZeneca) recently announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for the anticoagulant Brilinta (ticagrelor) and granted it priority review. The sNDA seeks approval for Brilinta, in combination with aspirin, to reduce subsequent stroke in patients who have experienced an acute ischemic stroke or transient ischemic attack (TIA).StrokeRisk.FDAThe Prescription Drug User Fee Act (PDUFA) target date for this sNDA has been set for the fourth quarter of 2020. If approved,Brilinta + aspirin will become the first to reduce subsequent stroke in these high-risk patientsStrokeDual antiplatelet therapy with dual efficacy.

This sNDA is based on the results of the Phase III THALES trial evaluating cardiovascular outcomes. The trial demonstrated that initiating treatment within 24 hours after an acute ischemic stroke or TIA, Brilinta combined with aspirin for 30 days significantly and clinically meaningfully reduced the risk of the primary composite endpoint of stroke and death compared to aspirin alone. The safety findings in this study were consistent with the known safety profile of Brilinta.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “Patients who experience an acute ischemic stroke or transient ischemic attack (TIA) are at high risk of subsequent strokes, which can be disabling or fatal. Today’s priority review reflects the potential of Brilinta as a much-needed treatment option to reduce the incidence of subsequent strokes in these patients. We look forward to working with”FDAcollaboration to enable Brilinta to benefit patients as soon as possible.”

Stroke (Image source: medlife.com)

THALES is an international, multicenter, randomized, double-blind, placebo-controlled, event-driven Phase III trial sponsored by AstraZeneca, involving more than 11,000 patients. The aim is to verify whether the combination therapy of Brilinta and aspirin is superior to aspirin monotherapy in preventing the composite endpoint of stroke and death in patients with mild acute ischemic stroke or high-risk transient ischemic attack (TIA).

In the study, these patients were randomized and treated for 30 days within 24 hours after the onset of symptoms of acute ischemic stroke or high-risk TIA. The experimental treatment consisted of a 180 mg loading dose of Brilinta administered as soon as possible on Day 1 after randomization, followed by 90 mg twice daily from Days 2 to 30, or matching placebo. All patients received open-label aspirin therapy, with 300–325 mg on Day 1 and 75–100 mg once daily from Days 2 to 30. The primary efficacy outcome was the time to the composite endpoint of stroke and death within 30 days of treatment. The primary safety outcome was the time to first occurrence of severe bleeding events as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) criteria. Patients were followed for an additional 30 days according to standard care.

High-level results from the study demonstrated that, compared with aspirin monotherapy, Brilinta 90 mg twice daily in combination with aspirin for 30 days achieved a statistically and clinically significant reduction in the risk of the primary composite endpoint of stroke and death. The preliminary safety results of the study were consistent with the known safety profile of Brilinta, with an increased rate of bleeding in the treatment group. The full results of the study will be published in a peer-reviewed journal and presented at an upcoming medicalConferencepublished above.

Dr. Clay Johnston, Dean of the Dell Medical School at the University of Texas at Austin and principal investigator of the THALES trial, previously stated: “The risk of secondary stroke is highest during the first few days and weeks following a mild acute ischemic stroke or high-risk transient ischemic attack (TIA). Although an expected increase in bleeding was observed, the THALES trial results demonstrated that the combination of Brilinta and aspirin reduced the risk of potentially devastating events during this critical period.”

Stroke is the second leading cause of death worldwide, with 6.2 million deaths attributed to stroke in 2017, including 2.7 million deaths from ischemic stroke. Patients who experience an acute ischemic stroke or transient ischemic attack (TIA) are at high risk for secondary ischemic events, particularly within the first 30 days after the initial event, with the highest risk occurring within the first 24 hours.

Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. To date, Brilinta has been approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for secondary prevention of cardiovascular events in patients at high risk of heart attack. In May 2020,FDAApproval of Brilinta U.S. Label Update to Include Reduction in the Risk of First Heart Attack or Stroke in Patients with High-Risk Coronary Artery Disease (CAD)

In acute coronary syndrome (ACS) or withMyocardial InfarctionIn patients with a history of myocardial infarction (MI), Brilinta combined with aspirin has been proven to significantly reduce the risk of major adverse cardiovascular events (myocardial infarction, stroke, or cardiovascular death). The regimen of Brilinta combined with aspirin is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) or in those with a history of MI who are at high risk for atherothrombotic events. (Bioon.com)

Original Source:Brilinta granted FDA Priority Review for the reduction of subsequent stroke in patients who had an acute ischemic stroke or transient ischemic attack