Brilinta FDA Approval History

FDA Approved: Yes (First approved July 20, 2011)
Brand name: Brilinta
Generic name: ticagrelor
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction, Ischemic Stroke, Prophylaxis

Last updated by Judith Stewart, BPharm on Nov 12, 2020.

Brilinta (ticagrelor) is a P2Y₁₂ platelet inhibitor indicated:

• to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
  Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
• to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).
• to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

Development timeline for Brilinta

Date	Article
Nov  6, 2020	Approval Brilinta Approved in the US to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Jun  1, 2020	Approval Brilinta Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease
Sep  3, 2015	Approval FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack
Mar 30, 2015	Approval FDA Approves New Crushing Option for the Administration of Brilinta
Jul 20, 2011	Approval FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
Feb  4, 2011	US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)
Jan 21, 2011	AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets)
Dec 17, 2010	AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets)
Sep 15, 2010	US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application
Jul 29, 2010	FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes
Nov 19, 2009	AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

Further information

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