CardioExchange Archive

April 7th, 2014

Dabigatran Approved for Treatment of DVT and PE

Larry Husten, PHD

Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban (Xarelto), […]

---

March 14th, 2014

Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery

Larry Husten, PHD

The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]

---

February 14th, 2014

FDA Once Again Rejects New Indication For Rivaroxaban

Larry Husten, PHD

The third time wasn’t the charm. The FDA today turned turned down — for the third time — the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA — for the second time — turned down the sNDA for rivaroxaban in […]

---

January 17th, 2014

FDA Panel Once Again Rejects ACS Indication for Rivaroxaban

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS)  indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise when […]

---

December 16th, 2013

Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS

Larry Husten, PHD

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and […]

---

December 5th, 2013

Large Study Finds Favorable Risk-Benefit Profile for the New Anticoagulants

Larry Husten, PHD

A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of […]

---

August 26th, 2013

Missing Data And The ATLAS ACS 2-TIMI 51 Trial

Sanjay Kaul, MD and Harlan M. Krumholz, MD, SM

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.

---

June 28th, 2013

FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients

Larry Husten, PHD

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of […]

---

May 24th, 2013

Rivaroxaban Gains Approval in Europe for ACS Indication

Larry Husten, PHD

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive […]

---

March 22nd, 2013

Europe and U.S. Diverge on Two New Drugs

Larry Husten, PHD

The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]

---