login
  Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

FDA advisory committee votes against approval of rivaroxaban for acute coronary syndrome


Thursday, 24 May 2012 12:04



On 23 May, the FDA’s Cardiovascular and Renal Drugs advisory committee voted six to four, with one abstention, against the approval of the oral anticoagulant rivaroxaban (Xarelto, Bayer Healthcare/Jansen Pharmaceuticals) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome in combination with standard antiplatelet therapy (aspirin with or without clopidogrel). 


Data from the pivotal phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa therapy to lower cardiovascular events in addition to aspirin with/without thienopyridine therapy in subjects with acute coronary syndrome) supported rivaroxaban’s new indication. Results from the study showed that rivaroxaban given in combination with standard antiplatelet therapy were superior to standard therapy alone in preventing secondary cardiovascular events in patients with acute coronary syndrome. There were also low rates of major bleeding events in coronary artery bypass graft (CABG) surgery. Despite these results, the FDA’s panel voted against based on missing data on early patient withdrawals.

The FDA assigned a priority review designation to the supplemental new drug application filed on 29 December 2011 for rivaroxaban in patients with acute coronary syndrome. Recommendations from the advisory committee will be considered by the FDA in its review, but the FDA is not required to follow them.

Rivaroxaban is currently approved in the USA to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, and to reduce the risk of both haemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.




Add New Comment

Related Items


Most popular


Tuesday, 12 Aug 2014
Toshiba has announced that it will feature SURESubtraction Coronary at The European Society of Cardiology (ESC) congress (30 August–3 September, Barcelona, Spain). Toshiba Introduces SURESubtraction Coronary at ESC 2014

Friday, 22 Aug 2014
Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration to market its precision planning application for transcatheter aortic-valve implantation (TAV... FDA 510(k) clearance for TAVI precision treatment planning application

CE mark approval for Agent drug-coated balloon
Friday, 25 Jul 2014
According to Boston Scientific, the Agent drug-coated balloon provides physicians with an additional alternative to treat both in-stent restenosis and de novo small vessel coronary disease. CE mark approval for Agent drug-coated balloon

Features


Drug-coated balloons for the management of coronary artery disease
Thursday, 04 Sep 2014
Robert Byrne writes that although drug-coated balloon therapy has been a significant innovation with relevance for everyday practice, convincing data in the coronary arena exists thus far only for ... Drug-coated balloons for the management of coronary artery disease

Transitioning from transfemoral to transradial: Why the transradial approach is here to stay
Thursday, 21 Aug 2014
William H Crowder believes that, despite some US interventional cardiologists’ reluctance to use the approach, the transradial approach will become standard of care for coronary catheterisation ... Transitioning from transfemoral to transradial: Why the transradial approach is here to stay

Profiles


David J Cohen
Wednesday, 04 Jun 2014
David J Cohen, director, Cardiovascular Research, Saint Luke’s Mid America Heart Institute, Kansas C... David J Cohen

Ashok Seth
Wednesday, 12 Feb 2014
Ashok Seth is the immediate past president of Cardiological Society of India and is the principal ... Ashok Seth

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions