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

MedStar author(s):

Citation: American Journal of Cardiology. 115(8):1154-61, 2015 Apr 15.PMID: 25728646Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Adenosine Monophosphate/aa [Analogs & Derivatives] | *Advisory Committees | *Congresses as Topic | *Coronary Disease/dt [Drug Therapy] | *Drug Approval/og [Organization & Administration] | *United States Food and Drug Administration | Adenosine Monophosphate/pd [Pharmacology] | Humans | Purinergic P2Y Receptor Antagonists/pd [Pharmacology] | United StatesLocal holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:

0002-9149

Name of journal: The American journal of cardiologyAbstract: 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. Copyright � 2015 Elsevier Inc. All rights reserved.All authors: Baker NC, Lhermusier T, Waksman RDigital Object Identifier:

http://dx.doi.org/10.1016/j.amjcard.2015.01.551

Date added to catalog: 2016-01-13

Holdings ( 1 )
Title notes ( 3 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article		Available		25728646

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

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. Copyright � 2015 Elsevier Inc. All rights reserved.

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