Johnson & Johnson one-ups Eliquis as Xarelto nabs $1.5B FDA nod in artery disease

Adding atherosclerosis to Xarelto's label could mean $1.5 billion in additional sales for J&J in the U.S., analysts figured. (Johnson & Johnson)

Johnson & Johnson and Bayer’s Xarelto, gradually losing share to Pfizer and Bristol-Myers Squibb’s Eliquis, just won a much-needed new indication analysts figure is worth $1.5 billion in the U.S. alone.

U.S. regulators approved Xarelto to reduce cardiovascular risks in patients with coronary artery disease (CAD) or peripheral artery disease (PAD), J&J said on Thursday. That makes it the first novel oral anticoagulant approved for that market, ahead of Eliquis and Boehringer Ingelheim’s Pradaxa.

The European Commission gave its go-ahead for J&J’s Xarelto partner Bayer in that indication in August.

Aspirin is the current standard of care for these conditions, known as atherosclerosis. But findings from Xarelto's Compass trial showed that the drug, in combination with aspirin, could pare down the risk of death, stroke and heart attack by 24% versus aspirin alone. Specifically, Xarelto reduced the stroke rate by 52%, the CV death rate by 22% and heart attack rate by 14%.

Right before the pair unveiled the data at the European Society of Cardiology (ESC) annual meeting last August, Credit Suisse analyst Vamil Divan, M.D., predicted that positive results could add some $1.5 billion sales annually in the U.S.

J&J could use that kind of money, as Eliquis has been encroaching on its market share. Beginning in the first quarter of 2017, Eliquis overtook Xarelto as the most prescribed drug in its class in the U.S., and Eliquis is also closing the gap in global sales.

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

On the company’s first-quarter earnings call, J&J pharmaceuticals chief Joaquin Duato—who recently expanded his title—said the CAD/PAD approval would help the company grab share in the anticoagulant market, and as it’s the only one in the indication, it’ll also gain a stronger position with payers.

But Xarelto’s other recent bids for new indications yielded clinical data that wasn't as glowing. At this year’s ESC meeting, J&J had to admit two defeats. Xarelto failed to top placebo at cutting blood clots and blood clot-related death in acutely ill patients who were just out of the hospital. That forced Jim List, M.D., Ph.D., Janssen R&D’s head for cardiovascular and metabolism, to pull up a previous study against Sanofi’s Lovenox to “tell a more complete story” about Xarelto’s power in those patients.

Then, in another study, Xarelto failed to reduce CV risk in heart failure patients whose symptoms had suddenly worsened.

By 2017 numbers, Xarelto's global sales of $5.64 billion were ahead of Eliquis’ $4.87 billion, but according to an analysis run by market intelligence firm EvaluatePharma in August, Eliquis’ sales will jump to $11.31 billion by 2024, while Xarelto's will stay around $5.83 billion.