Feature | April 29, 2015

FDA Advisory Committee Recommends Approval of Cangrelor Antiplatelet Therapy

Intravenous platelet inhibitor indicated for reducing thrombotic cardiovascular events in CAD patients undergoing PCI

The Medicines Company, cangrelor, FDA advisory committee, approval

April 29, 2015 — The Medicines Company announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 - 2 with one abstention to recommend approval of the investigational intravenous antiplatelet agent cangrelor as an adjunct to percutaneous coronary intervention (PCI). Cangrelor is indicated for reducing the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization.

The Committee recommendation is not binding on the FDA, which makes the final decision regarding approval and the indication and labeling. The company expects the FDA to complete its review of the NDA by June 23, 2015.

The Committee based its recommendation on the results of CHAMPION PHOENIX, an 11,145-patient Phase 3 randomized, double-blind clinical trial comparing cangrelor to oral clopidogrel in patients undergoing PCI.

Cangrelor is an immediately bioavailable and quickly reversible intravenous P2Y12 platelet inhibitor under development for the reduction of thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Cangrelor is not approved for commercial use in the United States. In March 2015, the European Commission granted marketing authorization for cangrelor, which will be marketed under the trade name Kengrexal.

The CHAMPION PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor. The results of PHOENIX were reported in March 2013.

Cangrelor can increase the risk of bleeding. The most common adverse reaction in clinical trials was bleeding (15.5 percent). In CHAMPION PHOENIX severe/life-threatening, moderate and mild bleeding events were more common with cangrelor than with clopidogrel and dyspnea was reported more frequently in patients treated with cangrelor than with clopidogrel.

For more information: www.themedicinescompany.com

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
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...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
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
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Overlay Init