Pink Sheet is part of the Informa Intelligence Division 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

ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.

Advertisement

Related Content

Merck’s Vorapaxar CV Outcome Follow-Up Success Not Ready To Become Standard
FDA Questions Evidence For Janssen’s Xarelto In Acute Coronary Syndrome
FDA Panel To Take Second Look After J&J Plugged Holes In Xarelto ATLAS Data
Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim
Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim
Xarelto, Pradaxa Difficult To Separate After Positive NICE Final Guidance
Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle
Bayer/J&J's Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa
Xarelto Approval For DVT Bodes Well For Coming Indications

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS074158

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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