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Brilinta granted US FDA Priority Review for stroke
Brilinta granted US FDA Priority Review for stroke.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 5186S\n AstraZeneca PLC\n 09 July 2020\n \n \n \n 9 July 2020 07:00 BST\n \n \n \n \n \n Brilinta\n \n granted FDA Priority Review for the reduction of subsequent stroke\nin patients who had an acute ischemic stroke or transient ischemic attack\n \n \n \n \n Brilinta in combination with aspirin could be the first FDA-approved dual\nantiplatelet therapy to reduce the rate of stroke in these high-risk patients\n \n \n \n \n AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) \n for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA)\n .\n \n \n \n \n \n The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the fourth quarter of 2020.\n \n \n \n \n The sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilinta 90mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.1 The results were in line with the known safety profile of Brilinta.1\n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: \"Patients who have had an acute ischaemic stroke or transient ischemic attack are at high risk of experiencing a subsequent stroke, which may be disabling or fatal. Today's Priority Review reflects Brilinta's potential as a much-needed treatment option to reduce the rate of subsequent stroke for these patients and we look forward to working with the FDA to make Brilinta available as soon as possible.\"\n \n The data from the THALES trial will be published in a peer reviewed journal and presented at an forthcoming medical congress.\n \n \n Brilinta is 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 the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack. In May 2020, the FDA approved a label update for Brilinta in the US to include t...