Posts Tagged ‘ATLAS ACS’

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August 26th, 2013

Missing Data And The ATLAS ACS 2-TIMI 51 Trial

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What is the impact of the larger than usual amount of missing data in the ATLAS ACS 2-TIMI 51? A member of the FDA’s Cardiovascular and Renal Drugs Advisory panel answers questions about this issue.


May 21st, 2012

Rivaroxaban for ACS Gets Positive FDA Review, but Questions About ATLAS Trial Conduct Persist

The FDA will offer generally positive – but also highly mixed – advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing […]


December 29th, 2011

J&J Applies for ACS Indication for Rivaroxaban (Xarelto)

Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients. Following a succession of failed trials, ATLAS was the first trial to […]


November 13th, 2011

ATLAS ACS 2-TIMI 51: Rivaroxaban Benefits Low-Risk ACS Patients

Results of the highly anticipated ATLAS-ACS 2–TIMI 51 trial demonstrate that ACS patients receiving standard therapy, including dual antiplatelet therapy, may benefit from the addition of the factor Xa inhibitor rivaroxaban, although at the cost of some additional bleeding complications. The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome  trial was […]


October 6th, 2011

Rivaroxaban Roundup: ATLAS-ACS an AHA Late-Breaker, NEJM Perspective, NYT Overview

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13, at 5:13 PM. Last week, Bayer […]