Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding cangrelor.
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.
Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Thibault
T
Lhermusier
Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Nevin C
NC
Baker
Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net.
Ron
R
Waksman
D000249:Adenosine Monophosphate / Q000031:analogs & derivatives* / Q000494:pharmacology; D026683:Advisory Committees; D003226:Congresses as Topic; D003327:Coronary Disease / Q000188:drug therapy*; D017277:Drug Approval / Q000458:organization & administration*; D006801:Humans; D058921:Purinergic P2Y Receptor Antagonists / Q000494:pharmacology; D014481:United States; D014486:United States Food and Drug Administration
D058921:Purinergic P2Y Receptor Antagonists; D000249:Adenosine Monophosphate; C117446:cangrelor