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

BMS/Pfizer’s Eliquis On Priority Review Path Toward March 2012 Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Priority review designation for the Factor Xa inhibitor suggests FDA sees it as a major treatment advance over Pradaxa and Xarelto in reducing the risk of stroke among atrial fibrillation patients.

You may also be interested in...



Genzyme Lemtrada’s Momentum Halts With FDA “Refuse-To File” Letter

The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.

Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim

The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.

Eliquis Superiority Claim May Be At Stake In “Complete Response” Letter

FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073097

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