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FDA approves ticagrelor for long-term use after ACS event
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AstraZeneca announced that a 60 mg twice-daily dose of its antiplatelet agent ticagrelor has been approved by the FDA for prevention of CV death, MI and stroke in patients more than 1 year after an ACS event.
Ticagrelor (Brilinta) was previously approved in a 90 mg twice-daily dose for use in patients up to 1 year after an ACS event for prevention of CV events and stent thrombosis, according to an AstraZeneca press release.
Approval for the expanded indication was based on the results of the PEGASUS–TIMI 54 study, according to the release. The PEGASUS-TIMI 54 results, presented at the 2015 American College of Cardiology Scientific Sessions and published in the New England Journal of Medicine, indicated that adding ticagrelor to low-dose aspirin reduced risk for CV death, MI or stroke in patients who had an ACS event at least 1 year prior.
Marc Sabatine
“While it’s important that physicians tailor their treatment approach for each patient, these data speak to the clinically important benefit that can be gained when adding ticagrelor to the current standard therapy in a patient population at increased risk for recurrent [CV] events in the long term,” Marc Sabatine, MD, MPH, chairman of the Thrombolysis in Myocardial Infarction [TIMI] Study Group at Brigham and Women’s Hospital and lead investigator for PEGASUS–TIMI 54, said in the release.
The drug is expected to be available in the newly approved dose by the end of this month, according to the release.
Disclosure: Sabatine reports financial ties with Abbott Laboratories, Accumetrix, Aegerion, Amgen, AstraZeneca, Bristol-Myers Squibb, Critical Diagnostics, Cubist, CVS Caremark, Daiichi Sankyo, Eisai, Genzyme, Gilead, GlaxoSmithKline, Intarcia, Merck, MyoKardia, Nanosphere, Pfizer, Quest Diagnostics, Roche Diagnostics, Sanofi-Aventis, Takeda, Vertex and Zeus Scientific. He also reports two pending patents related to the results of PEGASUS-TIMI 54.