Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Xarelto Faces Approval, Labeling Obstacles Even After Cmte. Endorsement

Executive Summary

Bayer and Johnson & Johnson may have won the battle in securing an FDA advisory committee endorsement of Xarelto (rivaroxaban) for atrial fibrillation, but they may well lose the war of the novel anticoagulants given the panel’s unfavorable labeling recommendations if the oral Factor Xa inhibitor is approved.

You may also be interested in...



ROCKET AF’s Design Causes Headaches For Xarelto Sponsors

Key design elements of the Xarelto pivotal trial in atrial fibrillation have come back to haunt sponsors Bayer and Johnson & Johnson during the course of the rivaroxaban NDA review.

Xarelto Review Puts FDA’s Comparative Effectiveness Stance To The Test

Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.

ROCKET AF’s Design Causes Headaches For Xarelto Sponsors

Key design elements of the Xarelto pivotal trial in atrial fibrillation have come back to haunt sponsors Bayer and Johnson & Johnson during the course of the rivaroxaban NDA review.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134531

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel