October 14, 2019

FDA Approves Xarelto for VTE Prevention in Acutely Ill Medical Patients

October 14, 2019—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE) in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

According to the company, the new indication allows Xarelto to be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. To date, the FDA has granted Xarelto eight indications, six of which are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence across a wide range of patient populations.

Alex C. Spyropoulos, MD, commented in the company’s announcement, “With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge. The phase 3 clinical studies in this high-risk patient group show us that Xarelto at the 10-mg dose is an effective and safe option to help prevent blood clots.” Dr. Spyropoulos is Professor of Medicine at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital in New York, New York.


October 15, 2019

Study Evaluates Preprocedural Anticoagulation for Patients With STEMI Undergoing Primary PCI

October 11, 2019

FDA Seeks Full-Time Medical Officers to Evaluate Cardiovascular Devices