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

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.

You may also be interested in...



Merck’s Vorapaxar CV Outcome Follow-Up Success Not Ready To Become Standard

Cardiovascular and Renal Drugs Advisory Committee says FDA should encourage lost-to-follow-up rates closer to what was seen in Merck’s TRA2P study of vorapaxar, but shouldn’t expect it.

FDA Questions Evidence For Janssen’s Xarelto In Acute Coronary Syndrome

Although FDA suggested the sponsor consider a limited duration of use for rivaroxaban in the ACS setting, advisory committee briefing documents reflect doubts about the strength of analyses supporting such a claim.

FDA Panel To Take Second Look After J&J Plugged Holes In Xarelto ATLAS Data

Broader issue of missing data in clinical trials could see further discussion as FDA’s Cardiovascular and Renal Advisory Committee will relook at Xarelto’s acute coronary syndrome indication Jan. 16, now that J&J has tried to address the missing data that befuddled the committee on the first go-round.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC143367

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