J&J, Bayer's Xarelto scores FDA nod to treat acutely ill patients during and after hospitalization

Johnson & Johnson and Bayer's Xarelto nabbed an FDA approval Monday to treat hospitalized acutely ill patients. (Johnson & Johnson)

Johnson & Johnson and Bayer’s Xarelto, once king of the warfarin alternative market, is now chasing chasing Pfizer and Bristol-Myers Squibb's Eliquis. But with a new approved indication in the books—its eighth—it's not backing down.

The FDA on Monday approved Xarelto to help prevent blood clots for acutely ill patients without a high risk of bleeding during and after hospitalization. The approval will allow patients who start the drug in the hospital to follow up at home for a recommended duration of 31 to 39 days, J&J said.

With Monday’s nod, Xarelto now has eight indications to its name—six of which specifically target blood clots. The New Jersey drugmaker is hoping that broad label goes a long way in helping Xarelto turn around declining sales. 

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In the second quarter, Xarelto posted a 19% decrease in stateside sales to $549 million. Several factors hurt Xarelto’s performance in the second quarter, Vice Chairman Joaquin Duato said in July.

More of Xarelto's scripts came from Medicare Part D patients in Q2 of this year compared with last, J&J said. And the drugmaker was on the hook for a bigger share of patient costs in Medicare Part D’s donut hole. Congress implemented the donut hole change last year, forcing drugmakers to pay more to move patients out of the coverage gap.

To get over the hump with those changes, Duato said J&J would focus on expanding Xarelto’s list of indications—and Monday’s FDA nod should help in that endeavor.

RELATED: ESC: New Pfizer, BMS real-world data could boost Eliquis in Europe

But getting a leg up will be a challenge as one Xarelto competitor—Eliquis—continues to run roughshod over the field.

Pfizer and Bristol’s med has not only outstripped the warfarin alternative market but has actually displaced warfarin itself as the most prescribed anticoagulant. That positive trend has given some analysts hope that Eliquis could become one of pharma’s biggest earners in a just a few short years. GlobalData predicts that Eliquis will be the second-highest earning drug in 2025 with $18.7 billion in sales, coming in behind Merck’s Keytruda at a predicted $22.5 billion.

Eliquis, which hit $2 billion in sales in the second quarter, has also piled onto its competitors with real-world data. In September, the drug posted results showing a lower rate of major bleeding than standard-of-care vitamin K antagonists (VKA), as well as Xarelto and Pradaxa from Boehringer Ingelheim.

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