FDA adds key label expansion to blockbuster anticoagulant

October 22, 2018

A new indication for rivaroxaban (Xarelto) has been approved by FDA.

A new indication for Factor Xa inhibitor rivaroxaban (Xarelto) has been approved by FDA.

Janssen Pharmaceutical Companies of Johnson & Johnson snagged expanded indication for its blockbuster anticoagulant drug Xarelto, which realized 2017 sales of $2.5 billion. Xarelto, in combination with aspirin, is now approved to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). It is the first-and-only Factor Xa inhibitor to be approved for this indication.

“The newly approved Xarelto 2.5 mg twice-daily vascular dose, when used with aspirin, is a significant breakthrough in the treatment of patients with stable CAD and PAD,” Paul Burton, MD, PhD, vice president of medical affairs, internal medicine for Janssen Scientific Affairs, LLC, told FormularyWatch. “The regimen is shown to be highly effective and well-tolerated in preventing devastating and potentially irreversible CV events.”

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"Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD," said Kelley Branchi, MD, associate professor in cardiology at the University of Washington, Seattle, in a statement from Janssen. "As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5 mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations."

The COMPASS trial showed a significant 24% reduction of the risk of major CV events in patients with chronic CAD and/or PAD with the Xarelto 2.5 mg vascular dose twice daily plus aspirin 100 mg once daily, compared to aspirin alone, Janssen said.

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Patients realized a 42% reduction in stroke, a 22% reduction in CV death and a 14% reduction in heart attack.

The risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.

FDA’s approval of the Xarelto 2.5 mg vascular dose makes it the first and only Factor Xa inhibitor approved to reduce the risk of major cardiovascular events in the more than 13 million Americans with CAD and PAD, Burton said.

The wholesale acquisition cost (WAC) of Xarelto-immediately available at pharmacies-is $6.985 per pill and $13.969 per day (2 pills).

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