9th Jul 2020 09:45
(Alliance News) - AstraZeneca PLC on Thursday said the US Food & Drug Administration has accepted a supplemental new drug application and granted priority review to Brilinta for the reduction of subsequent stroke in patients who had an acute ischemic stroke or transientrischemic attack.
The Cambridge-based pharmaceutical company said the approval of Brilinta - or ticagrelor - was based on results from the Phase III Thales trial, which showed Aspirin combined with Brilinta resulted in a significant reduction in the risk of stroke and death, compared to Aspirin alone.
"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," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
AstraZeneca shares were trading 0.2% lower at 8,566.00 pence each on Thursday morning in London, but are 12% higher than at the start of the year.
By Ife Taiwo; [email protected].
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