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:

Related Content

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
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals | October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals | October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals | September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals | September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals | May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Feature | Pharmaceuticals | May 16, 2017
May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal
Prescribing Patterns Change Following Direct Marketing Restrictions
News | Pharmaceuticals | May 05, 2017
A study of how policies restricting pharmaceutical promotion to physicians affect medication prescribing found...
EBBINGHAUS study, evolocumab, repatha, statin therapy, cognitive issues, ACC.17 study
News | Pharmaceuticals | April 03, 2017
There is no evidence that adding a new cholesterol-lowering drug to treatment with a statin causes memory loss or other...
synthetic HDL-C injection, cholesterol, arterial plaque, heart attack patients, CARAT trial, ACC.17, clinical study
News | Pharmaceuticals | March 29, 2017
Injection of a novel form of synthetic high-density lipoprotein cholesterol (HDL-C), or good cholesterol, into the...
Overlay Init