Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding cangrelor

The American Journal of Cardiology
Thibault LhermusierRon Waksman

Abstract

Landmark clinical trials have established the benefit of P2Y12 inhibitors in the setting of acute coronary syndrome and percutaneous coronary intervention. On February 12, 2014, the Medicines Company (Sponsor) presented efficacy and safety data regarding cangrelor to the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee. The Sponsor sought approval for 2 indications: (1) in the setting of percutaneous coronary intervention for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with coronary artery disease and (2) in the setting of bridging therapy in patients with acute coronary syndrome or with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted because of surgery. The following is a summary of the data presented to the FDA by the Sponsor, the FDA's clinical review of cangrelor.

References

Aug 25, 2001·The New England Journal of Medicine·S YusufUNKNOWN Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators
May 2, 2007·Circulation·Donald E CutlipUNKNOWN Academic Research Consortium
Jul 17, 2007·Thrombosis Research·Steven R SteinhublWendell S Akers
Nov 6, 2007·The New England Journal of Medicine·Stephen D WiviottUNKNOWN TRITON-TIMI 38 Investigators
Nov 27, 2007·Journal of the American College of Cardiology·Kristian ThygesenUNKNOWN Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction
Jun 2, 2009·Netherlands Heart Journal : Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation·H J BoumanJ M Ten Berg
Sep 1, 2009·The New England Journal of Medicine·Lars WallentinMona Thorsén
Oct 10, 2009·Expert Review of Cardiovascular Therapy·José Luis FerreiroDominick J Angiolillo
Nov 17, 2009·The New England Journal of Medicine·Robert A HarringtonDeepak L Bhatt
Nov 17, 2009·The New England Journal of Medicine·Deepak L BhattUNKNOWN CHAMPION PLATFORM Investigators
Aug 20, 2010·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Bonnie B DeanMatthew F Emons
Jan 19, 2012·JAMA : the Journal of the American Medical Association·Dominick J AngiolilloUNKNOWN BRIDGE Investigators
Mar 12, 2013·The New England Journal of Medicine·Deepak L BhattUNKNOWN CHAMPION PHOENIX Investigators
Sep 3, 2013·The New England Journal of Medicine·Gilles MontalescotUNKNOWN ACCOAST Investigators

❮ Previous
Next ❯

Citations

Jan 14, 2016·British Journal of Pharmacology·Sven Nylander, Rainer Schulz
Mar 12, 2015·Pharmacotherapy·Suprat S WilsonPhillip D Levy
May 20, 2015·High Blood Pressure & Cardiovascular Prevention : the Official Journal of the Italian Society of Hypertension·Teresa StrisciuglioEmanuele Barbato
Jul 24, 2015·Drugs·Gillian M Keating
Jun 21, 2015·The American Journal of Cardiology·Ron WaksmanThibault Lhermusier
Jun 21, 2015·The American Journal of Cardiology·Iñigo LozanoEduardo Segovia
Jan 7, 2017·World Journal of Transplantation·Aparna Dalal
Sep 30, 2015·Therapeutic Advances in Respiratory Disease·Kelly Kuk, Jennifer L Taylor-Cousar
Dec 19, 2015·Statistics in Medicine·Lisa M LaVange, Thomas Permutt
Feb 19, 2016·Statistics in Medicine·Neal ThomasRoderick J A Little
Aug 12, 2018·American Journal of Clinical Dermatology·Paras P VakhariaJonathan I Silverberg
Dec 24, 2016·British Journal of Pharmacology·Elaine Unemori
Jun 15, 2016·CPT: Pharmacometrics & Systems Pharmacology·S Mehrotra, J Gobburu

❮ Previous
Next ❯

Related Concepts

Related Feeds

Cardiovascular Disease Pathophysiology

Cardiovascular disease involves several different processes that contribute to the pathological mechanism, including hyperglycemia, inflammation, atherosclerosis, hypertension and more. Vasculature stability plays a critical role in the development of the disease. Discover the latest research on cardiovascular disease pathophysiology here.

Cardiovascular Diseases: Risk Factors

Cardiovascular disease is a significant health concern. Risk factors include hypertension, obesity, dyslipidemia and smoking. Women who are postmenopausal are at an increased risk of heart disease. Here is the latest research for risk factors of cardiovascular disease.