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FDA Approves New Crushing Option for the Administration of Brilinta

March 30, 2015 -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved a new administration option for acute coronary syndrome (ACS) patients who are unable to swallow Brilinta 90 mg tablets whole. Unlike other P2Y12 inhibitors, Brilinta has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.

“We know that some patients who experience a heart attack are unable to swallow medications whole, yet it is important for these patients to receive and continue their oral antiplatelet therapy,” said Steven Zelenkofske, DO, Vice President, US Medical Affairs, Cardiovascular, AstraZeneca. “This label update, like the recent announcement of the PEGASUS TIMI-54 results, is an example of our ongoing commitment to addressing important unmet patient needs through advancing our understanding of Brilinta.”

In the general population, survey data show that 40% of adults experience problems swallowing pills. This difficulty may increase with age. Moreover, some patients who experience a heart attack have difficulty swallowing medications in the emergency setting. This new administration option for Brilinta gives healthcare professionals flexibility in treating their ACS patients.

Brilinta is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with 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, myocardial infarction (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 percutaneous coronary intervention (PCI), it also reduces the rate of stent thrombosis.

Brilinta has been studied in ACS in combination with aspirin. Maintenance doses of aspirin > 100 mg decreased the effectiveness of Brilinta. Avoid maintenance doses of aspirin > 100 mg daily.

About Brilinta (ticagrelor) Tablets

Brilinta is an oral antiplatelet treatment for ACS. Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). Brilinta works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular (CV) events, such as a heart attack or CV death, in patients with acute coronary syndrome (ACS). Brilinta is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, Brilinta should be used with a maintenance dose of 75 mg - 100 mg aspirin once daily, 81-mg aspirin dose in the US.

Brilinta is a registered trademark of the AstraZeneca group of companies.

About Acute Coronary Syndrome (ACS)

ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions include unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI). The conditions are defined by ECG changes and heart muscle enzyme leakage. Non–ST-elevation acute coronary syndrome (NSTE-ACS) includes unstable angina (UA) and non–ST-elevation myocardial infarction (NSTEMI); the term is usually used before heart muscle enzymes have been analyzed. The goal of treating ACS is to restore, improve, and/or stabilize blood flow to the heart muscle and to reduce the risk of recurrent CV events. Depending on the severity of the condition and the resources available, the patient will either be managed with medicines or undergo more invasive procedures. These procedures may include using catheters, balloons, and/or stents that treat the narrowed arteries of the heart called percutaneous coronary intervention (PCI) and/or a type of surgery that improves blood flow to the heart called coronary artery bypass grafting (CABG).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.

Source: AstraZeneca

Posted: March 2015

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Brilinta (ticagrelor) FDA Approval History

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