News | December 14, 2009

New Drug Application Submitted for Anti-Platelet Agent

December 14, 2009 – A new drug application (NDA) was recently submitted to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral anti-platelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists inhibit the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.

The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. AstraZeneca said its submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. The phase III study investigated whether the inhibition of platelet aggregation seen with ticagrelor in phase II trials could lead to a reduction of cardiovascular events in the full spectrum of ACS patients, which includes patients hospitalized for unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).

PLATO involved 18,624 ACS patients in 43 countries and was designed to provide a comprehensive analysis of efficacy, safety and tolerability of ticagrelor. The study design reflected real world clinical practice by enrolling the full spectrum of ACS patients within 24 hours of their index event, and evaluating their outcomes regardless of whether they were medically managed or underwent invasive procedures such as PCI or coronary artery bypass graft surgery.

Ticagrelor is the first in a new chemical class, the CPTPs (cyclo-pentyl-triazolo-pyrimidines). Ticagrelor is chemically distinct from the thienopyridines, such as clopidogrel and prasugrel.

For more information: www.astrazeneca-us.com

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Overlay Init