CardioExchange Archive

March 26th, 2012

Rivaroxaban Found Safe and Effective for Pulmonary Embolism

Larry Husten, PHD

In recent years rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF patients, and as additional therapy to conventional antiplatelet therapy in ACS patients. Now, a study presented at the American College of Cardiology meeting in Chicago and published simultaneously in […]

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March 1st, 2012

Decision on Apixaban (Eliquis) Pushed Back By 3 Months

Larry Husten, PHD

Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The […]

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February 28th, 2012

FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients

Larry Husten, PHD

The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of […]

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December 29th, 2011

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

Larry Husten, PHD

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 […]

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November 13th, 2011

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

Larry Husten, PHD

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 […]

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November 4th, 2011

FDA Approves Rivaroxaban for Stroke Prevention in AF

Larry Husten, PHD

The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the […]

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October 6th, 2011

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

Larry Husten, PHD

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 […]

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September 29th, 2011

Rivaroxaban Meets Primary Endpoint in ATLAS ACS TIMI 51

Larry Husten, PHD

Bayer AG announced today that in the ATLAS ACS TIMI 51 trial, rivaroxaban (Xarelto, Bayer and Johnson & Johnson) had met the primary efficacy endpoint  in patients with acute coronary syndrome (ACS). The drug was associated with “a statistically significant reduction in the rate of events for the primary composite endpoint of cardiovascular death, myocardial infarction […]

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September 23rd, 2011

Rivaroxaban (Xarelto) Gets Positive Recommendation for AF and DVT in Europe

Larry Husten, PHD

The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF, according to Bayer HealthCare. CHMP has also recommended the drug’s approval for the treatment of DVT and for the prevention of recurrent DVT and PE following acute DVT. […]

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September 8th, 2011

FDA Advisory Panel Gives Yellow Light to Rivaroxaban

Larry Husten, PHD

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers, […]

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