ESC: Johnson & Johnson hunts for silver lining as Xarelto bombs blood clot, heart failure studies

xarelto
Xarelto couldn't meet primary endpoints in either of two trials. (Johnson & Johnson)

At last year’s European Society of Cardiology annual meeting, Johnson & Johnson was touting data that put its clot-busting Xarelto on track for a new approval worth $1 billion-plus. Not so this year.

Instead, J&J was forced to admit Xarelto had flopped—not once, but twice. The company said Monday that in two separate studies, the anticoagulant drug had failed to top a dummy pill at fending off the potentially deadly blood clots it's designed to treat.

In the first, dubbed Mariner, Xarelto didn't pare down a composite endpoint of blood clots and blood-clot-related death in acutely ill patients—those suffering from conditions such as heart failure, infectious diseases or ischemic stroke—after their hospital stays. But J&J’s Janssen unit thinks it may still have a potential approval on its hands.

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The reason? Janssen has already tested Xarelto in this population with a study called Magellan, which showed long-term Xarelto use topped long-term use of enoxaparin, known by brand name as Lovenox from Sanofi, at cutting down on clots. That trial’s results weren’t all rosy, either, though: They showed Xarelto increased bleeding risks, too.

Still, the combined results from Mariner and Magellan “tell a more complete story” about Xarelto’s role in staving off clots in “appropriate acute medically ill patients” both in and out of the hospital, Jim List, Janssen R&D’s head for cardiovascular and metabolism, said in a statement, adding that “we see a filing pathway towards approval with these combined findings and look forward to discussing them” with the FDA.

In the second study unveiled at ESC, adding Xarelto to standard-of-care treatment didn’t reduce the risk of heart attack, stroke or death among heart failure patients whose symptoms had suddenly worsened.

RELATED: Big trial failure for Xarelto in clot prevention won’t affect sales, Bayer vows

The failures aren't the first for J&J, which has been aggressive in hunting down new Xarelto indications. Just last October, for instance, J&J's partner Bayer stopped a Xarelto study in certain stroke patients because the drug wasn't likely to beat aspirin at fending off a second stroke or embolism.

But the companies have also turned up data to support some big new uses—most recently, aspirin-topping artery disease results that analysts have predicted could help generate $1.5 billion in U.S. sales. And as Janssen’s List was quick to point out, the company has other Xarelto studies on the horizon that should be reading out soon.

RELATED: Pfizer, BMS' Eliquis takes J&J's next-gen anticoagulant market-share crown

Xarelto, which rival Eliquis from Pfizer and Bristol-Myers Squibb has booted from the top of the atrial fibrillation heap, could use some new green lights. Once a slow-launching drug at the bottom of its class, Eliquis has zipped to the front of the new-age oral anticoagulant pack to put Xarelto in second place.

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