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.
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.
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.
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.