Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Panel Again Rejects Wider Use of J&J’s Xarelto

By Drug Discovery Trends Editor | January 16, 2014

A panel of Food and Drug Administration experts again rejected Johnson & Johnson’s bid to expand use of its blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.
 
The condition occurs when narrowed blood vessels restrict blood flow to the heart, increasing the risk of heart attack and other potentially deadly problems.
 
The FDA panel on Thursday voted unanimously against the broader use of the pill, saying too much information is missing from company studies to accurately gauge Xarelto’s benefit. The same panel also voted against wider approval in 2012. The FDA has twice rejected J&J’s application since then. The agency is not required to follow the panel’s advice, though it often does.
 
J&J already markets the pill for three patient groups: Those with irregular heartbeats, those undergoing hip or knee replacement surgery, and those at risk of blood clots in the legs.
 
FDA panelists expressed concern about bleeding side effects linked to the pill and the large number of patients who dropped out of company studies. J&J attempted to address those concerns by proposing that patients only use Xarelto for 90 days, a relatively short time period for which the company has more data. But even for that timeframe, FDA panelists said that there was too much missing information to consider approving the drug, given its safety risks.
 
“Everybody, even the sponsor, would agree that this drug increases the risk of bleeding,” said Dr. Steven Nissen, an FDA panelist and chairman of cardiology at the Cleveland Clinic. “And in that context the quality of the data becomes increasingly important.”
 
J&J Vice President Paul Burton said in a statement that the company “will work with the FDA to address questions raised today.”
 
The New Brunswick, N.J.-based company reported Xarelto sales of $246 million in its last fiscal quarter.
 
Date: January 16, 2013
Source: Associated Press

Filed Under: Drug Discovery

 

Related Articles Read More >

Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
Prime time for peptide-based drug discovery 
Why smaller, simpler molecular glues are gaining attention in drug discovery
Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation
Unlocking ‘bench-to-bedside’ discoveries requires better data sharing and collaboration
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE