News | April 30, 2015

FDA Grants Priority Review for Potential New Indication for Brilinta

Review based on PEGASUS-TIMI 54 study evaluating Brilinta for chornic secondary prevention of atherothrombotic events in heart attack patients

Brilinta, AstraZeneca, FDA, sNDA, PEGASUS-TIMI 54, new indication

April 30, 2015 — AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for Brilinta (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

The PEGASUS TIMI-54 study was presented during the opening late-breaking clinical trial session of the American College of Cardiology’s 64th Annual Scientific Session and Expo and was also simultaneously published in the New England Journal of Medicine online.

PEGASUS-TIMI 54 is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 patients, was the first study in the program. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischemic stroke or transient ischemic attack, and in patients with diabetes and coronary atherosclerosis.

Brilinta is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with peripheral arterial disease, stroke, diabetes or atherosclerosis.

Brilinta 90-mg tablets are 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 endpoint 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.

For more information: www.astrazeneca.com

Related Content

Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Jardiance Improves Life Expectancy for Adults With Type 2 Diabetes and Cardiovascular Disease
News | Pharmaceuticals | October 11, 2018
Novel results from the landmark EMPA-REG OUTCOME trial suggest that treatment with Jardiance positively impacts life...
Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive
News | Pharmaceuticals | September 04, 2018
The jury is still out on whether people at moderate risk of a first heart attack or stroke should take daily aspirin to...
Blood Pressure and Cholesterol-lowering Drugs Continue to Improve Survival After a Decade
News | Pharmaceuticals | August 27, 2018
Blood pressure and cholesterol-lowering drugs continue to improve survival in patients with hypertension after more...
Pfizer Announces Positive Topline Results from Phase 3 ATTR-ACT Study
News | Pharmaceuticals | April 06, 2018
Pfizer Inc. announced that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study met its primary endpoint...
Humanetics Presents Data on Drug to Protect Cardiac Cells From Space-Like Radiation

Photo from NASA

News | Pharmaceuticals | February 01, 2018
February 1, 2018 –Humanetics Corporation (Humanetics) has recently completed two research studies funded by the Natio
Overlay Init