ACC: J&J, waiting for $1.5B FDA nod, touts more aspirin-topping Xarelto data in artery disease patients

J&J's Xarelto is waiting for the FDA to grant it approval for use with aspirin in patients with peripheral artery disease and/or coronary artery disease. (Image: Johnson & Johnson)

ORLANDO, Fla.—Johnson & Johnson has once again bolstered its case for a Xarelto artery disease approval.

Sunday at the American College of Cardiology's 67th Annual Scientific Session, the company trotted out a new study showing that, compared with solo aspirin, the med cut the incidence of major limb problems among peripheral artery disease (PAD) patients by 43%—and in turn pared down amputations, deaths and hospitalizations.

RELATED: J&J's Xarelto combo tops aspirin in artery disease, cueing $1.5B in U.S. sales

PAD can lead to blockages in arteries in the legs and feet, severely reducing blood flow. But the new data reinforce Xarelto's potential benefits in this group "and may offer additional insight into how physicians manage patients with PAD in the future,” Peter DiBattiste, global cardiovascular development head at J&J’s Janssen unit, said in a statement.

The results are part of a new analysis of the pharma giant’s Compass trial, which last August showed that a Xarelto-aspirin pairing could beat out aspirin alone at reducing the likelihood of cardiovascular events in patients with PAD and/or coronary artery disease (CAD). Putting Xarelto into the mix slashed the combined risk of death, stroke and heart attack by 24%.

RELATED: J&J's Xarelto pads artery disease case by reducing amputation, death rates vs. aspirin

And now, the New Jersey drugmaker is waiting for an FDA green light that could potentially pad U.S. sales by $1.5 billion each year, analysts have guessed. According to J&J’s pharma chairman, Joaquin Duato, 6 million to 7 million patients are potentially eligible for Xarelto treatment if it can snag a go-ahead in artery disease.

If it does, Xarelto would be the first in its class of novel oral anticoagulants to do so, a distinction J&J seems to enjoy. When it comes to indication count, Xarelto safely leads main rivals Eliquis from Pfizer and Bristol-Myers Squibb and Pradaxa from Boehringer Ingelheim, though Eliquis has come from behind to overtake the J&J product in terms of total prescriptions.