AstraZeneca (NYSE: AZN) today announced that BRILINTA™ (ticagrelor) tablets, a new oral antiplatelet therapy, is now available in pharmacies in the United States.
BRILINTA received approval from the U.S. Food & Drug Administration (FDA) on July 20, 2011, and is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina [UA], non--ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis. BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
Initial steps in the launch process following the U.S. FDA approval of BRILINTA include working with distribution partners and pharmacy customers to ensure BRILINTA is available to order for use in hospital-based patients, and also for patients to fill by prescription in U.S. pharmacies.
Now that BRILINTA is available in the U.S., AstraZeneca will continue to work with hospitals, government and managed care reimbursement bodies to ensure BRILINTA is reimbursed, and listed on hospital formularies and treatment protocols. Navigating these steps, which are necessary before BRILINTA will be available to a substantial number of incident ACS patients, will be a key focus for the next 12 months.
"Every year, more than one million Americans are hospitalized with ACS. The U.S. approval and launch of BRILINTA means that physicians now have access to a new treatment option for patients with ACS that is proven to be more effective than clopidogrel at reducing heart attack and cardiovascular death when taken with low-dose aspirin (less than 100mg)," said Alex Gold, MD, Executive Director of Clinical Development, BRILINTA, AstraZeneca.
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