US FDA approves Xarelto for AF patients

Published: 7-Nov-2011
Regulatory

To cut the risk of stroke in this patient group


The US FDA has approved Bayer/Johnson & Johnson anti-clotting drug Xarelto (rivaroxaban) to prevent stroke in people with irregular heart rhythm (non-valvular atrial fibrillation).

The approval is based on the results of a clinical trial with more than 14,000 patients, which showed that Xarelto was equivalent to anti-clotting drug warfarin in terms of its safety and efficacy.

The approval comes just a few months after the US regulator approved Xarelto to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.

The FDA has added a black box safety warning to the drug to make clear that people using the drug should not discontinue it before talking to their doctor, as discontinuing the drug can increase the risk of stroke.

Xarelto is marketed in the US by Titusville, new Jersey based Janssen Pharmaceuticals.

The drug is one of three new anticoagulant treatments that are looking to replace warfarin. The others are Boehringer Ingelheim’s Pradaxa (dabigatran), which the FDA approved for stoke prevention in AF patients more than a year ago, and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), which expects an FDA decision on the same licence within the coming months.

  • Companies:
  • Johnson and Johnson
  • US Food and Drug Administration (FDA)
  • Bayer
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