Feature | June 22, 2012

FDA Panel Does Not Recommend New ACS Indication for Xarelto

Janssen said it will work with FDA to address issues for its use in acute coronary syndromes

June 22, 2012 — The the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted in May against recommending approval of expanding the indication for rivaroxaban (Xarelto).  The drug’s maker, Janssen Research and Development LLC, wants to expand the indication to include the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The FDA recently issued a response letter regarding the drug’s supplemental new drug application (sNDA), which the company is evaluating and said it will address the agency's questions.

Xarelto is approved for three clinical uses in the United States: To reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, to reduce this risk in people who have just had hip replacement surgery and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem. Janssen submitted this sNDA in December 2011 and received a priority review designation from the FDA in February.

Healthcare market research firm Decision Resources recently surveyed U.S. cardiologists and managed care organization (MCO) pharmacy directors. Respondents said reducing the incidence of mortality is the greatest unmet need in post-myocardial infarction and Xarelto is being watched as a possible pharmaceutical solution. 

“Despite the declining rate of deaths due to myocardial infarction and despite the emergence of novel antiplatelet agents and optimal statin therapy, the incidence of mortality remains the attribute that most influences surveyed cardiologists’ prescribing decisions in post-myocardial infarction,” said Decision Resources analyst Conor Walsh, Ph.D. “According to clinical data and thought leaders we interviewed, Bayer/Janssen’s Xarelto has demonstrated the potential to significantly fulfill this unmet need.”

For more information: www.janssenrnd.com

Related Content

anticoagulants, U.S. market, Technavio, 2020, trends
News | Antiplatelet and Anticoagulation Therapies| May 25, 2016
Technavio’s latest report on the U.S. anticoagulants market provides an analysis on the most important trends expected...
Watchman, left atrial appendage closure, LAA occluder, LAA. LAAO, laa occluder, left atrial appendage, Watchman

The Boston Scientific Watchman device is currently the only transcatheter LAA occluder cleared for use in the United States.

Feature | Left Atrial Appendage (LAA) Occluders| May 20, 2016 | Dave Fornell
Atrial fibrillation (AF) affects nearly 6 million Americans and the condition puts them at significantly greater risk
News | Atrial Fibrillation| May 19, 2016
Physician-researchers in the College of Medicine at the University of Cincinnati have developed a computerized decision...
clot, coronary thrombus, antiplatelet therapt, DAPT

An intravascular ultrasound (IVUS) image of a thrombus formed in a coronary artery.  While there are guidelines for antiplatelet therapy, there are still questions over the duration of such therapy. 

Feature | Antiplatelet and Anticoagulation Therapies| May 19, 2016 | Marianne Pop, Pharm.D., BCPS
There are many opinions on the duration of dual antiplatelet therapy (DAPT), highlighted at the 2016 American College

A Medtronic CoreValve TAVR device being deployed under angiographic image guidance.

 

Feature | Heart Valve Technology| May 16, 2016
 
PROMETHEUS, anticoagulation in women
News | Antiplatelet and Anticoagulation Therapies| May 16, 2016
May 16, 2016 – Women younger than 55 years of age who undergo percutaneous coronary intervention (PCI) for acute coro
daily oral anticoagulation therapy, OAT, atrial fibrillation, as needed, HRS 2016 study
News | Antiplatelet and Anticoagulation Therapies| May 09, 2016
A new study shows the use of novel anticoagulants to treat atrial fibrillation (AF) on an “as needed basis” guided by...
warfarin, atrial fibrillation, dementia, Intermountain Healthcare Study, HRS 2016
News | Antiplatelet and Anticoagulation Therapies| May 09, 2016
A new study has found an increased risk of dementia in patients with atrial fibrillation (AF) that receive long-term...
warfarin, atrial fibrillation, kidney failure, HRS 2016
News | Antiplatelet and Anticoagulation Therapies| May 06, 2016
Atrial fibrillation patients taking warfarin are at higher risk of developing kidney failure if anticoagulation levels...
Overlay Init