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This is the eighth indication approved for Xarelto.
Rivaroxaban (Xarelto, Janssen) has snagged its eighth indication-this time to prevent blood clots in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.
With FDA’s approval of this new indication, Xarelto can 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-the most of any direct oral anticoagulant (DOAC)-six of which are specifically for the treatment, prevention and reduction in the risk of recurrence of VTE across a wide range of patient populations,” said Janssen in a statement.
"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," said Alex C. Spyropoulos, MD, professor of medicine at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, in the statement.
“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,” Spyropoulos added.
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More than 7 million Americans are hospitalized each year with an acute medical illness, which is a broad term used to describe serious, yet common, medical conditions, Janssen said. These patients are at increased risk of blood clots for up to 3 months after hospital discharge, with 80% of events happening within the first six weeks.
In response to the burden of VTE in hospitalized patients, the Surgeon General issued a Call to Action in 2008 for key stakeholders to build a coordinated plan that could lead to a reduction in VTE across the US. “However, a recent study found that in-hospital VTE rates continue to rise and more work is needed to reduce the burden of VTE especially among those at lower risk,” Janssen said.
"Preventing blood clots is a critical priority for physicians treating patients with acute medical illnesses, which is why Janssen is pleased that the FDA approved the use of Xarelto to address this often fatal, yet preventable condition," said James List, MD, PhD, global therapeutic area head of Cardiovascular & Metabolism for Janssen Research & Development, in the statement.