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J&J, Bayer's Xarelto gets US nod for expanded use in patients


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J&J, Bayer's Xarelto gets US nod for expanded use in patients

The U.S. Food and Drug Administration approved the expanded use of Johnson & Johnson and Bayer AG's Xarelto to prevent blood clots in another patient population.

Xarelto can now be used to prevent venous thromboembolism, or VTE, in acutely ill patients who are at the risk of developing blood clot complications but are not at a high risk of bleeding. VTE refers to a blood clot that starts in a vein.

The company said Xarelto can be initiated for such patients during hospitalization and after discharge for a duration of 31 to 39 days.

Xarelto is approved for eight indications, six of which are specifically for treating, preventing and reducing the risk of recurrence of VTE across different patient populations.

Xarelto is marketed outside the U.S. by Germany-based Bayer and in the U.S. by Johnson & Johnson.

In March, the companies agreed to pay about $775 million to settle almost all of the approximately 25,000 lawsuits in the U.S. related to the blockbuster drug where plaintiffs alleged that the medicine caused uncontrollable and irreversible bleeding that led to injuries and even deaths.